JPS59500802A - Fertility detection methods and devices - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Fertility detection methods and devices Background of the invention The invention generally relates to the evaluation of changes that occur before, during, and after the ovulation process. 9 relates to the field of detecting the onset of ovulation in women. More specifically, this invention naturally accumulates in the vagina for the purpose of providing natural contraception and enhancing fertility. The most sensitive aspects of the human menstrual cycle can be determined by observing cyclical changes in the daily volume of cervical-vaginal fluid. It concerns the method of determining the most fertile period and the equipment involved.

the cultural or religious beliefs of the people, and their concerns about hormonal Due to the growing demand for simple, practical, convenient and reliable There is considerable interest in reliable and effective birth control methods. Furthermore, conception If you want.

The egg can be fertilized for approximately 12 to 24 hours after ovulation, so it is important to accurately determine the timing of ovulation. The ability to detect is essential. Therefore, a simple method to detect the onset of ovulation is to It is also desirable for strengthening abilities.

For the past 20 years, for purposes of birth control and fertility enhancement.

Much research has been done to develop techniques and devices for detecting ovulation time. . The onset of ovulation can be detected with a high degree of accuracy using a variety of modern techniques.

Currently, these methods do not indicate that ovulation has already begun or is about to begin. It can be shown accurately. However, each of these methods has some drawbacks. It is therefore easy to use and allows women to provide medical assistance and/or non-confidential treatment. As a method that can make accurate judgments without using complicated test methods, its practicality and reliability are There is a problem with reliability.

One clinical method that is recommended to detect when you are ovulating is.

A certain degree of discomfort in the pelvic region during the middle of the menstrual cycle, i.e., the expected time of ovulation. It depends on the woman's ability to know. Belly due to ovarian expansion or ruptured follicles Irritation of the membranes is thought to be the cause of this “intermediate pain.”Unfortunately, most of patients do not experience monthly ``intermediate pain'' or cannot reliably identify it. Therefore, this method is not a widely applicable or reliable method for detecting ovulation. Not the way it comes.

For a long time, the physical properties of cervical mucus have allowed clinicians to estimate the approximate fertile period. It has been used to know. Recently, Hilgers et al. Man L45 Wings, 52575-582, (1981).

Ovulation is marked by cervical mucus signs (profuse mucus discharge, fern formation, traction and minimal viscosity). It was confirmed that this occurs between 3 days before and 3 days after the final day of the test (elasticity). Cervical mucus is A hydrogel secreted by the cervix and specially designed for clinical testing. The sample must be taken from the cervix by a medical professional using a specially designed instrument. Women are Cervical mucus cannot be collected by oneself using such methods or devices. commonwealth National Patent No. 3.926,037. Ik 4,002,056. lk 4 , 013,066 and Illo, , 3,979,945.

To detect ovulation, the color or Self-observation of viscoelasticity has also been recommended as a method of birth control. Wi Luzon, M, A,,l! li! Van Nostrand, the Lu1l Summer Executioner's Negotiation Reinbold Company.

New York (Wilson, M. A., The 0vulation Me thod of BirthControl, Van No5trand R e1nhold Co, N, Y,) 1980゜“Ovulation method” or’BiB In its current form, this birth control method, called the 111in method, is to identify the characteristic appearance of mucous discharge at the vaginal opening midway through the menstrual cycle. It depends on the ability of women to Cervical mucus and vaginal fluids even during ovulation This method is recommended due to the fact that some women have low secretion, making it difficult to identify signs of mucus. Applying the law becomes difficult. Research on fertility regulation using this technique for birth control purposes Some show failure rates as high as 25%.

[Moghissi, K, S, , Fertil.

5teri1. ) 34 89 (1980); World Health Organization, “Natural Family” Schedule of trials at multiple centers of planned ovulation methods. ■. “Effective stage” (8 Pr. ospective Multicentre Trial of the 0 vulation Method of Nat-ural Family Pl anning, Il, The Effectiveness Phase) 2 13I (Fertil, 5teri1.), 36.591 (198 1),) Probably ovulation detection, which is currently popular and widely used. The method is to record your body temperature when you wake up in a basal state on a graph. basic body A significant increase in body temperature (BBT) usually occurs 1-2 days after ovulation. non-fertile period To be certain, three consecutive BBT readings must be less than the temperature of the previous six days. It must be at least 0.2°C (about 0.36°F) higher. (Mogishi, Ke I, varnish.

Higoko JJ, 34.89 (1980). This method has several drawbacks.

Since only the basal state can be used, the three female subjects had 6 to 8 hours of sleep, and their eyes I have to take my temperature as soon as I wake up. Physical activity and/or alcohol the night before ingestion of alcohol or intermittent infections.

It will show the wrong temperature. What is very important is that the BBT measurement is It does not indicate when ovulation occurs, but rather shows evidence of ovulation 2 or 3 days after it begins. The goal is to bring about the following. In addition, women accurately judge basal body temperature charts. It is often difficult to

Many other attempts to detect ovulation rely on biochemical analysis of epithelial or endometrial samples. This involves histological examination and observation of hormone levels in the blood. All of these require medical expertise and complex equipment, and are not suitable for self-use. Not yet.

Several attempts have been made to discover an easy way to self-detect when you are ovulating when you are fertile. This is reflected in the United States Patent. Preti et al. 1 US Patent No. 4 , 119,089 using gas chromatography.

emissions by monitoring the concentration of volatile sulfur-containing compounds present in the air in the mouth. Although it is a method of predicting and determining the egg stage, it is not a practical technique for home use. stomach.

A more recent technique developed for personal use is Polish UK), as described in US Pat. No. 4,15L833. This method is , II! Teach to detect ovulation by measuring the water content of the I cavity It uses a short history made of water-absorbing polymer. The implementation of this method is I inserted a short history into my vagina for about 8 hours a day.

This method detects an increase in the water content of cervical mucus by measuring the diameter of the cervical mucus. It is claimed that the increase is indicative of the onset of ovulation. This method uses it Practical drawbacks experienced by women 1. For example, during sexual intercourse when a small pill is inserted. discomfort and interference with sexual activity. More importantly, this method has several There is a drawback in terms of judgment.

Cervical mucus is a hydrogel from which water is difficult to extract. Furthermore, the vagina The contents include epithelial cells, bacteria, and jelly-like glycoprotein fibers (from cervical mucus). It contains particulate matter and also contains water, including serum transudate. human tissue, including vaginal tissue. Many of the tissues in the body are 90% water, so a short history of hydrophilic substances may be present in the vaginal environment for a long time. Determine which moisture content the short history method is measuring during exposure across the water There's no way. Short history swelling represents the uptake of water over a long period of time, during which The history itself may influence the water balance of vaginal tissues. to the menstrual cycle The correlated water changes are due to the large amount of water that is necessarily absorbed over a period of about 8 hours. It tends to be obscured by full capacity. Furthermore, the swelling of the short history is due to the increase in diameter. The probability of inaccuracy is high because it can only be measured.

Additionally, swelling is a function of the absorbent capacity of the polymer. All these shortcomings are this one The law does not provide a reliable and accurate means of self-detecting ovulation. It shows that

Therefore, despite the numerous prior techniques described for ovulation detection5. It is easy to use and judge for yourself to know the fertile period of menstrual cycle. A simple and reliable method remains desired.

fi powder The present invention provides a method for detecting fertile and non-fertile periods of the human menstrual cycle. and devices, based on the cyclical changes in cervical-vaginal fluid that occur during the aforementioned cycles. It is. The term "cervical-vaginal fluid" as used below refers to the mucinous secretion from the cervix, and secretions from the vaginal wall containing sloughed lung cells, bacteria, white blood cells, and cervical endometrial cells This is the fluid inside the human vagina that consists of fluid that leaks into the vagina.

The method of the present invention has been devised so that nine women can use it themselves, and it is and does not require medical assistance. When performing this method, the area adjacent to the cervix should be Cervical-vaginal fluid from the anatomical part of the vagina (posterior vaginal fornix) is collected using a syringe-like aspirator. Collect daily.

Collection is performed once a day, and the cervical-vaginal fluid accumulated over a 24-hour period is collected. . This sampling procedure is referred to as “sampling J.” The amount of liquid that (referred to as weight J).

This allows women to experience the follicular phase (before ovulation), ovulation phase and luteal phase (before ovulation) of a menstrual cycle. (after) to identify distinctive patterns over a period of continuous measurement from records that are reliably correlated with It becomes possible to know.

By implementing this method, a woman can recover from early follicular phase, that is, postmenstrual It is now possible to observe low average sample volumes or weights of fetal cervical-vaginal fluid. Ru. As ovulation approaches, the volume or weight of the sample of vaginal fluid increases. increases to 2-31E before ovulation or at the time of ovulation, the sample volume/weight should be This indicates the period when the baby is most likely to conceive. Entering the non-fertile luteal phase is detected by a decrease in the sample volume/weight of the cervico-vaginal fluid; Shows a low average value. By observing the above changes, a woman can determine her conception period and It can be used for both contraception and conception. .

The present invention also includes an aspirator for collecting cervical-vaginal fluid, which can easily have a volume of It is desirable to mark the scale so that measurements can be made.

This suction device is designed to collect fluid from the vaginal fornix at the back of the vagina near the cervix. It prevents perforation of vaginal or cervical tissue and is therefore easy and painless to operate.

In its preferred form, the suction device is sterilely packaged and disposable after a single use. It is. Cervical-vaginal fluid in this device may be disposed of after recording measurements, but If analysis is necessary, it can be transferred to a test tube and chemically analyzed by medical personnel. come. In addition, the suction device allows observation of the color, translucency and viscosity of the cervical-vaginal fluid. It is preferable that the material be made of a transparent material, and the characteristics of the cervical-vaginal fluid described above will depend on the period of conception and It is an additional means of determining the non-fertile period.

The methods and devices of the invention can also be used in conjunction with other ovulation detection methods, such as basal body temperature methods. The accuracy of the method can be increased.

Other features and advantages of the invention will become apparent upon consideration of the following description.

Brief description of the drawing FIG. 1 is a perspective view of a cervico-vaginal fluid aspirator according to the present invention.

FIG. 2 is a sectional view taken along line 2-2 in FIG. 1.

FIG. 3 is an enlarged view of the opening and tube of the suction device.

FIG. 4 is a cross-sectional front view of the suction device taken along line 4-4 in FIG.

It is along the vertical plane of the surface of the opening.

FIG. 5 is an anatomical diagram showing the proper positioning of the three inventive suction devices.

Figure 6 shows the basal body temperature of one subject during each menstrual cycle using the method of the present invention. This is a graph of

Figure 7 is a graph of daily sample volume for the same menstrual cycle for the same subject as in Figure 6. be.

Figure 8 shows the same menstrual cycle of the same subject as the graphs of Figures 6 and 7. Logarithmic graph of immunoglobulin G and albumin concentrations per m12 expressed as ■. It is f.

Intermediate J-'s Shizuka-Kakata Eikun [ The method of the present invention is an objective and simple method for determining reproductive endocrine and physiological Simply based on measurable phenomena.

The one phase of the menstrual cycle that begins with menstruation is the follicular phase, or reproductive phase.

Hormonal signals from the hypothalamus stimulate the anterior pituitary gland to release follicle-stimulating hormone ( FSH) is released. Due to the influence of FSI+, follicles in the ovary grow and become est. It secretes rogens, which produce reproductive changes in the uterus and vagina. of the menstrual cycle Toward the midpoint, serum estrogen levels increase from LH (pituitary to It reaches its peak approximately one day before the peak of secreted luteinizing hormone (luteinizing hormone).

This causes the follicle to rupture within 16 to 24 hours and release a mature egg (ovulation). υ1 Following the egg, the ruptured follicle becomes the corpus luteum, which secretes progesterone, and this hormone Serum levels of cancer increase. If conception does not occur, GJ and progesterone production will be approximately It fades after a week and menstruation begins a few days later. (yen, varnish, varnish, see, and Earl, be, chafe! AJA5-Bunko Philadelphia: Saunder s.

1978, pp. 126-151 (Yen, S, S, C, and R, B, J Affe.

Reproductive Endoc [-button peeling μhi, Ph1ladelph ia: 5oundcrs+1978+pp, 126-151)).

In response to estrogen, the amount of cervical mucus secreted into the cervix increases greatly and Cervical mucus secretion rapidly decreases during ovulation and the luteal phase when gesterone is secreted. Do a little. The mucus mixes with fluid in the vagina and forms a pool of cervico-vaginal secretions. how much Estrogen and progesterone affect the amount of this fluid secreted from the vaginal wall. It is not well known whether the Invention with a concept not previously understood The source of this is the collection of cervical-vaginal secretions for volume or weight measurement. In other words, "sampling" involves aspirating cervical secretions directly from the cervix. In contrast to that.

It is an excellent indicator of the fertile and non-fertile periods of a woman's menstrual cycle. . Volume and weight of cervical-vaginal fluid samples taken daily over one cycle It shows a remarkable pattern in correlation with the follicular phase (pre-ovulation), ovulation phase and luteal phase.

The early follicular phase is associated with low levels of estrogen, typically 100 to 2 A sample volume/weight of less than 0.00 microliters of cervical-vaginal fluid is obtained. Exclusion As the egg approaches, the sample volume/weight of cervico-vaginal fluid increases markedly. Forecast A few days before or at the time of ovulation, when estrogen levels are at their highest. , peak sample volume/sample weight, called volume peak/weight peak, is observed. , which is 3 to 40 times the sample volume 7 weight obtained at the early follicle stage. capacity/ Cervical--vaginal fluid near or at peak weight, sample volume 7 weight compared Not only is there a large amount of color, but the translucency and sliminess with varying degrees of change are noticeable. .

The most fertile state is the first or second day after peak volume/weight. Capacity/weight After the peak, the sample volume/weight steadily decreases to 1/3 of the peak volume/weight. It will go below. During the latter period, samples of cervico-vaginal secretions were collected by volume/weight. Not only is it less sticky, but it has a glue-like, white viscosity with almost no slimy appearance. I can't see it at all. Low sample volume approximately 1/3 J g below volume/weight peak If the amount/weight continues for 2 days, it is determined that the fertile period has changed to the non-fertile period.

In this way, the method of the present invention can be carried out by collecting cervical-vaginal fluid from the vaginal cavity (sampling) by yourself. sample volume or sample weight of cervical-vaginal fluid daily over a period of time. It involves recording the amount and observing the pattern of the resulting capacitance or M amount. after menstruation The daily cervical-vaginal fluid collection of 1 woman is a low average sample of early follicular (non-fertile) period. It is desirable to recognize volume/weight, ie, baseline characteristics.

However, one method requires collection at least a few days before the scheduled ovulation, at the time of ovulation, and at the time of ovulation. It is effective if done over several days after ovulation and ovulation. Implement this method cervico-vaginal fluid samples should be collected at approximately the same time each day, preferably by eye. It is preferable to collect it when you wake up. However, the amount detected by implementing this method is The pattern of changes in volume and weight is consistent regardless of when sampling occurs during the day, and , even if the sampling interval is somewhat longer or shorter than 24 hours, it is clear and certain that It is something that can be recognized.

Intercourse 6-8 hours before collection does not adversely affect the predictive power of the method. Ta Even if intercourse is close to the time of sampling.

Semen present in the cervical-vaginal fluid will only produce falsely high readings.

The reading is if the woman is near ovulation and is using this method for birth control. indicates that unprotected sex should be avoided.

When using this method for natural family planning, the sample volume M/weight begins to increase. or r21 day rule” (subtract 21 from the shortest period in the past 6 months) ) After the date calculated by 1M, sexual intercourse that does not result in pregnancy shall be avoided. yellow not pregnant After entering the body phase, ie.

Volume/M Weight - After 2 consecutive days of low sample volume/weight after May resume unprotected sex. During this period.

This takes into account the period of ovulation as well as the survival period of sperm for 3 to 4 days.

The reverse applies when using the method to promote conception.

Intercourse should be performed on or after the day of peak volume/weight, which is estimated to be the most fertile period. It is best to do it on the day of

The method is further explained below in the description of the cervico-vaginal fluid aspirator according to the invention. . Details of this instrument are shown in Figures 1 to 4, and all pertinent information regarding the operation of the instrument is included. and Anatomy - The relationship of the instruments to human tissues and organs is shown in FIG.

Shown generally as 8 in FIG. 1 is a cervico-vaginal fluid aspirator according to the present invention.

The suction device 8 consists of an elongated cylindrical tube 10 with a continuous passage inside it. 26, one end of which is the opening 12. The length of the tube 10 is the same as that of the suction device 8. When fully inserted, the opening 12 reaches the posterior vaginal fornix 36 (FIG. 5). , it is desirable that the length be sufficient. In addition, the length of the tube 10 can be corrected by removing air bubbles. It is possible to manipulate the liquid inside the tube 10 so that accurate measurements can be made. Aperture 12 is a tube 10 enlarged into a spherical shape (the tip is spherical).

The most detailed enlarged view is shown in FIG. 3, which shows the vagina 32 or Alternatively, this is to prevent trauma or perforation of the tissue of the cervix 30. The spherical opening 12 is As shown in FIG. 4, the front surface is oval.

It easily slides into the posterior vaginal fornix (Fig. 5) of the vagina 32, which is the lower part of the cervix 30. can be done.

Guy F' that holds the opening I2 of the suction device 8 in the optimal position when inserted into the vagina 32 16 is located at the end of tube 10 opposite opening 12.

The guide 16 has a length of the elliptical front surface of the opening 12 with respect to the elliptical front surface of the opening 12. The shaft 28 is positioned so as to be parallel to the longest side 40 of the rectangular guy I.16. child The desired orientation of is most clearly shown in FIG. Opening 12 of guide 16 The orientation of the front surface of the opening 12 is such that the longitudinal axis 28 of the front surface of the opening 12 6 and the posterior (dorsal) wall 48. (Figure 5).

When the suction device 8 is in place, the suction force that draws the cervico-vaginal fluid into the passageway 26 is: It is produced and discharged by a suction plunger, indicated generally at 24. The desire shown in Figure 2 In a preferred embodiment, plunger 24 is movable within passageway 26 and It consists of a shaft 14 projecting from one passage. The axis 14 is indicated generally at 44 near the opening. It has an inner end and an outer end 42, with the outer end generally projecting from the tube 10. Inner end of shaft 14 44 has a tip 18 which is flexible to snugly fit into the passageway 26. Preferably, it is formed of a rubber-like material. Tightly fitted flexible tip 18 is moved from a first position abutting the opening 12 to a second position along the tube 10. This creates a force that draws cervico-vaginal fluid into passageway 26. The flexible tip 18 The fact that it fits tightly into the passageway 26 means that the cervical-vaginal fluid sucked into the passageway 26 is 9. It also prevents the liquid from flowing beyond the position of the tip 18.

The suction alleviation means 22 relieves the suction force generated by using the suction device, and reduces the suction force to Prevents the pressure exerted on the vaginal and cervical tissues from causing tissue damage or pain. To prevent. In the preferred embodiment shown in FIGS. 2 and 3, this suction relief means 2 2 is in the form of a narrow channel 22 extending along the length of the tube 10 to the outside of the tube; 2 is separate from the passage 26 and does not communicate with the passage. For sufficient suction relief In the desired position, the channel 22 is located on the anterior wall of the vagina 32 when the suction device 8 is inserted. It is desirable to face 46.

FIG. 5 shows two suction devices 8 of the present invention inserted into the vagina 32. Opening of suction device 8 12 is located in the posterior vaginal fornix 36 of the vagina 32 below the cervix 30. plastic from the position where the plunger 24 contacts the opening 12.

Upon movement away from the opening 12, suction is created to draw the cervical-vaginal fluid into the aspirator. 8 into the passage 26. In this position, the suction device 8 extracts the maximum amount of cervical-vaginal fluid. Obtainable. When the user takes out the suction device 8, the scale 20 attached to the tube 10 Cervical-vaginal fluid volume can then be measured. Preferably, between one division of scale 20 The intervals are in increments of 50 microliters (0.05 ml).

The method preferably includes measuring the amount of fluid collected into the suction device on each day of the menstrual cycle other than on menstrual days. It is necessary to measure and record the amount of liquid mentioned above.

50 overall observed by one subject using the method and suction device of the present invention A unique pattern (Figure 7) was observed when subjects measured their daily basal body temperature during the same menstrual cycle. Compare this with the table (Figure 6).

The accuracy of ovulation detection of the present method is graphically demonstrated. In both charts, comprehensive What is indicated by 60 is the 34th day and the 1st to 8th days, which are one menstrual day. No. In Figure 7, no volume samples were taken on these menstrual days. From the 9th Until day 33, the subject collected samples at the same time every day using the inhaler of the invention. The sample volume of cervical-vaginal fluid was recorded. Cervical-vaginal fluid from days 9 to 18 A slight increase in 52 was observed, but the average value during this time was approximately 400 μl. . There was a significant increase on the 19th day, and a clear increase on the 20th day, right around the time of ovulation. This indicates that it is a very fertile period. Capacity peak that occurred on the 20th day Following day 54, cervico-vaginal fluid volume decreases to levels around day 24, post-ovulation, i.e. , showed a luteal phase Haeslein volume of 56, indicating inability to conceive. follow hand.

The use of this method allows the subject to know that her fertile window is approximately from day 19 to day 2. It was shown that it is most likely to occur over two days.

The last day of hypothermia 58, that is, the day estimated to be the ovulation day according to the basal body temperature method, is the 21st day. This is the day following the capacity peak in FIG.

FIG. 8 is a logarithmic graph showing changes in the amounts of two types of components in cervical-vaginal fluid. graph The two components shown are immunoglobulin G and albumin. These ingredients are Each capacity is steadily decreasing at its peak. Figure 8 is the same as Figures 6 and 7. It is correlated with the same menstrual cycle. Immune clopurin G and and albumin concentrations are similar to those of these components when pure cervical mucus is analyzed. It correlates with turn, but the concentration of components in pure cervical mucus is much higher. shoe Maher, G, B, F.

(Schumacher, G, B, F,) +'Body fluid in the female genital cavity Immune factors and their changes during the menstrual cycle, the skin side -1 town, Dhindsa/Schumacher ) Compilation, (Elsavia North Holland, Inc.).

1” (Lilscvier North l1olland, Inc.) + 1980) a Another advantage of the one-horn method is that it reduces the chance of pregnancy for couples who cannot conceive. When prescribed to improve the possibility of pregnancy, cervical-vaginal fluid can be analyzed in the laboratory. The goal is to make it possible to collect and store raw materials.

A characteristic pattern of sample volumes of cervical-vaginal fluid of repeated in subjects and correlated with basal body temperature, and in this pattern The non-fertile period before and after the fertile period is characterized by low average capacity. Ovulation is approaching In all subjects, there was a noticeable, old, and easily determined "capacity peak." nine.

This is indicated by an increase in the sample volume of cervico-vaginal fluid called .

Volume P peak indicates that ovulation occurs between 20 days after the volume peak day. neck - When vaginal fluid volume returns to a low average value similar to the pre-ovulatory period.

The subject entered a luteal phase in which she was unable to conceive.

The following example shows results obtained using the method and device to determine the onset of ovulation or the period of conception. Show results.

Example-V 18 cases of ovulation in 7 healthy female volunteers between the ages of 19 and 33 A research study on the menstrual cycle was conducted.

All subjects had their cervical and vaginal secretions removed by suction at home according to the present invention. A sample was taken. Daily samples were collected in pre-weighed vials (colors). The weight of the sample was measured by the inventor in the laboratory. day of menstrual cycle Lumpur weight as a function was analyzed in this study. However, compared to moisture Since the mass density of cervical-vaginal secretions is only slightly higher, the sample weight is proportional to the volume. It is possible to consider them to be equal, and 8! '', the difference is negligible.

Along with daily sample collection, subjects performed a morning BBT 1ill determination.

Several patients experience "mid-term pain" at the time of ovulation, and if this is observed it should be recorded It was done. Estimated ovulation day is the last day of low BBT and if "mid-term pain" is observed. The date was set as that day.

The functions of cycle day and sample weight (volume) do not match in 18 cases 1 and 1. Ru. There is a sample size baseline before ovulation.

In the early stages of follicles, the average value for the first 4 days after menstruation is below 100-200■ (/JI2) It was. (Also in the case of 7 ovulation, the sample volume is the base of the early preovulatory period) The amount of line increased rapidly to 3 to 40 times. This is the peak capacity. 18 cases of menstrual cycle In 9 of these cases, the volume peak was 6.0 times greater than the preovulatory baseline; Furthermore, in 15 of the 18 cases, the ovulation was 4 times higher than the preovulatory baseline. observation The lowest volume peak produced was three times the pre-ovulatory baseline. of the subjects Capacity peaks ranged from 300 to 1300 mg (μp).

Some subjects had relatively small volumes of cervico-vaginal secretions, with peak volumes of approximately 300μ There were also people who were seven-year-olds. However, their volume peak significantly exceeds the preovulatory baseline. It is easy to know the fertile period. For women with less cervical mucus -, the daily sampling method is extremely useful in determining the fertile window. . In this study, the 1 volume peak was generally 2 U before estimated ovulation (range 0 to 4 to 1). It happened to. Of the 18 cycles investigated, 7 patients had 8 bars 2 days before estimated ovulation. 7 cases peaked one day before estimated ovulation, and 3 cases peaked one day before estimated ovulation. It peaked on the day of estimated ovulation.

The remaining cycles showed a capacitance peak with a wide range.

Can J? − Subject EK, used the method and device of the present invention for five consecutive menstrual cycles. I have detected my fertile period. Table ■ shows 1. Herbs collected using the suction device of the present invention. Cervical-vaginal fluid volume and laboratory-measured weight records for cycles 2-5. It shows the correlation with basal body temperature over the period of time. In period 2, only the capacity is recorded in E. I recorded it.

The results in Table I show that the volume or weight peaks of the recording can be easily determined. This indicates the approximate beginning of the fertile period and the nearness of ovulation. and low average zombile volume or weight during the pre-ovulatory follicular phase and post-ovulatory luteal phase. It's a contrast. On the peak day, ovulation occurs slightly before the rise in body temperature. It shows a favorable correlation with the BBT display. Is it a comparison between the records of this method and the BBT method? It is easy to see that cervical-vaginal fluid increases significantly over several days when the basal body temperature changes. , and how to determine the volume and weight records to detect and determine the timing of ovulation. It is obvious that it is only accurate and easy.

The above examples have been set forth for clarity of understanding and do not limit the scope of the invention. It's not something you do. Changes in both method and equipment are not recommended for those skilled in the nine techniques. Seems obvious.

- As an example, the suction relief described in the preferred embodiment as one longitudinal groove. The means may be several grooves arranged around the tube, shorter channels or concentrically arranged. It can be replaced with other embodiments such as a groove.

Similarly, one method is to collect immunoglobulin G or albumin from the collected cervical-vaginal fluid. It was explained that it makes it possible to analyze the chemical components of Other liquids It is also possible to analyze the chemical composition of Also detects chemical changes during the two menstrual cycles as other formats.

Detects the presence or properties of liquid components such as soluble proteins or pH It is also possible to place an indicator on the inside of the tube.

This method and device can be correlated with observable changes in the biological aspects of the cervico-vaginal fluid. I can also do it. The present invention provides three-color consistency and translucency of each sample of cervico-vaginal fluid. It is possible to observe changes in these parameters as well as the transition between non-fertile and fertile periods. yields detectable information about movement. From the early follicular period to the fertile period, the cervical - A marked increase in the translucency and viscosity of the vaginal fluid can be observed, as well as from the fertile period. During the period of transition to the luteal nonconception period, the highest translucency and viscosity change to a whitish paste-like state. can be observed to change.

FIG. 6 period B cycle day ---------IGG FIG.8

Claims (1)

[Claims] 1. A method for detecting the fertile and non-fertile periods of the human menstrual cycle. Cervical-vaginal fluid was collected daily from the vagina for a period of 2 days, and the volume of the fluid was A method consisting of establishing periodic patterns of changes in quantities. 2. In the method according to claim 1, the above-mentioned collection procedure includes measuring the above-mentioned cervical-vaginal fluid on a scale. A method consisting of taking a sample into an inhaler. 3. In the method according to claim 1, the above-mentioned collection procedure is performed at the same time every 24 hours. How to be done. 4. By the method of claim 1, after the above-mentioned collection and confirmation procedures, the above-mentioned neck is - A method comprising storing vaginal fluid and chemically analyzing said stored fluid. 5. By the method of claim 4, the volume pattern of the cervical-vaginal fluid is determined by the chemical and A method consisting of correlating periodic changes in biological components. 6. In the method according to claim 4 or 5, the above-mentioned analytical procedure is performed using immunochlorin G. and analysis of albumin. 7. A method for detecting the fertile period and non-fertile period of the human menstrual cycle. Cervical-vaginal fluid was collected daily from the vagina over a period of 20 days, and the above-mentioned A method consisting of determining a periodic pattern of changes in the weight of a liquid. 8. The method of claim 7, wherein said collection procedure comprises measuring said cervico-vaginal fluid on a scale. A method consisting of taking a sample into an inhaler. 9. In the method according to claim 7, the above-mentioned collection procedure is performed at the same time every 24 hours. How to be done. 10. In the method according to claim 7, further, after both the above-mentioned collection and confirmation procedures, The procedure consists of storing the aforementioned cervical-vaginal fluid and chemically analyzing the aforementioned stored fluid. How to do it. 11. By the method of claim 10, the weight pattern of the cervical-vaginal fluid is determined by the chemical influence of the fluid. and correlating periodic changes in biological components. 12. In the method according to claim 10 or 11, the above-mentioned analytical procedure is performed on immunoglobulins. Method consisting of analysis of phosphorus G and albumin. 13. A series carried out once - a day for at least several days before and after ovulation. Determining the fertile and non-fertile periods in the human menstrual cycle using the following procedures: The above procedure can be done in a way that Collect cervical-vaginal fluid that naturally accumulates in the vagina during normal daily intervals, and collect as previously described. Measure and record the volume of cervical-vaginal fluid during the menstrual cycle. It consists of establishing patterns of changes in volume, thereby determining the fertile window. Early follicular phase and non-conceptual luteal phase after 9 months when the onset of ovulation and ovulation are close. indicated by an increase in volume contrasting with a low average volume of This period contrasts with the low mean volume of the non-conceptual early follicular phase and the non-conceptual luteal phase after one month. A method indicated by a significant capacity peak. 14. The method of claim 13, wherein said collection procedure collects said cervico-vaginal fluid by eye. A method consisting of collecting a sample into a coated aspirator. 15. In the method of claim 13, the above collection procedure is performed at the same time every 24 hours. How it is carried out. 16. In the method of claim 13, after the above-mentioned sampling and confirmation procedures, the above-mentioned A method comprising storing cervical-vaginal fluid of a patient and chemically analyzing said stored fluid. . 17. By the method of claim 16, the volume pattern of the cervical-vaginal fluid is determined by the chemical influence of the fluid. and correlating periodic changes in biological components. 18. In the method of claim 16 or 17, the above-mentioned analytical procedure is performed on immunoglobulin Method consisting of analysis of phosphorus G and albumin. 19. A series performed once - days for at least several days before and after ovulation Determining the fertile and non-fertile periods in the human menstrual cycle using the following procedures: The above procedure can be done in a way that Collect cervical-vaginal fluid that naturally accumulates in the vagina during normal daily intervals, and collect as previously described. The weight of the cervical-vaginal fluid was measured and recorded, and the weight during the menstrual cycle was determined from the above record. It consists of establishing patterns of changes in volume, thereby determining the fertile window. The onset of ovulation and the early nonconceptional follicular phase and nonconceptional luteal phase after one month are close to ovulation. indicated by an increase in weight as opposed to a low average weight of 1. In addition, most of the fertility The high period contrasts with the low mean weight of the non-conceptual early follicular phase and the non-conceptual luteal phase after 1 month. method as indicated by a significant capacitance peak. 20. The method of claim 19, wherein said collection procedure collects said cervico-vaginal fluid by eye. A method consisting of collecting a sample into a coated aspirator. 2. In the method of Claim 19, 3. The above-mentioned collection procedure is carried out at the same time every 24 hours. method carried out. 22. In the method of claim 19, after the above-mentioned collection and determination devices, the above-mentioned A method comprising storing cervical-vaginal fluid of a patient and chemically analyzing said stored fluid. . 23. By the method of claim 22, the weight pattern of the cervical-vaginal fluid is determined by the chemical influence of the fluid. and correlating periodic changes in biological components. 24. The method according to claim 22 or 23, in which the above-mentioned analytical procedure Method consisting of analysis of brin G and albumin. 25. Whole cervix from the vaginal cavity with the vaginal wall and the cervix located at the proximal end of the vagina -1! i This is an instrument for collecting F fluid, and the aforementioned instrument is not intended for female subjects to use by themselves. A long cylindrical tube with a continuous passageway for insertion into the vaginal cavity. , an opening for suctioning cervical-vaginal fluid is arranged at one end of the aforementioned tube, and said opening is placed in a predetermined position. means to prevent trauma or perforation of the vaginal wall or cervical tissue when the and means for easily inserting said opening into the posterior vaginal lid of said vaginal cavity. Contained in the mouth. holding said opening in said position when said opening is within said vaginal cavity; means are provided at the end of said tube opposite said opening, said instrument being in front of said tube. When in said vaginal cavity, a suction force is created within said passageway to draw said cervical-vaginal fluids into said passageway. an instrument having means for suctioning into said passageway of said tube. 26. A device according to claim 25, which is provided in said pipe means for carrying said device. A means of reducing the aforementioned suction force when withdrawn from the vaginal cavity, thereby reducing the aforementioned suction force. consisting of something that prevents tissue damage or pain due to the pressure created by gravitational forces utensils. 27. The device of claim 26, wherein said means for relieving said suction force is It consists of a groove extending along the length of the tube. said channel being clearly separate and distinct from said longitudinal passage within said tube; , appliances that do not communicate with each other. 28. The device of claim 25 for detecting the chemical characteristics of the aforementioned cervical-vaginal fluids. A device having an indicator means within the aforementioned passageway for. 29. The device according to claim 25, having a volume on the outer surface of said tube over its entire length. An instrument with a scale. 30. The device of claim 25, wherein said retaining means is substantially rectangular. Ingredients. 31. The device of claim 25, wherein said opening is spherically enlarged and has an elliptical shape. A device that has a shape. 32. The device of claim 25, wherein said retaining means holds said opening in said Apparatus consisting of means for monitoring that it is properly held in place. 33. The device of claim 25, wherein said retaining means is substantially rectangular; A device in which the aforesaid opening is spherically enlarged and has an elliptical shape. 34. The device of claim 33, wherein said rectangular retaining means has a longest side thereof. is oriented parallel to the long axis of said oval opening, and The holding means is in the aforesaid predetermined position and the aforesaid opening means is in an appropriate position. by observing the orientation of said rectangular holding means. utensils. 35. The device according to claim 25, wherein the absorption generating means has the above-mentioned characteristics, Said inner end is located closer to said opening than said outer end, and said suction The collection means also has a tip provided at the said inner end of the said shaft, the said tip The end is drawn into the aforementioned passageway and allows the cervical-vaginal fluid to flow beyond the aforementioned tip. have means to prevent this. utensils. 36. Cervical-vaginal fluid is collected from the vaginal cavity with the vaginal wall and the cervix located at the upper end of the vagina. The above-mentioned equipment can be used by female subjects on their own. , providing a continuous passageway through a long cylindrical tube for insertion into the vaginal cavity, as previously described. An opening for receiving cervical-vaginal fluid is disposed at one end of the tube means, and said instrument is inserted into said vaginal cavity. a suction force for aspirating said cervical-vaginal fluid into said passageway of said canal when It includes the means to produce. When removing the above-mentioned device from the vaginal cavity, the above-mentioned suction force is relaxed and the above-mentioned suction force is used. A means of preventing tissue damage or pain due to the pressure created by established. utensils. 37. The device of claim 36 for detecting the chemical characteristics of the aforementioned cervical-vaginal fluids. 1 device having an indicator means within the aforementioned passageway. 38. The device of claim 36, wherein the outer surface of said tube has a volume along its entire length. An instrument with a scale. 39. The device of claim 36, wherein said opening is spherically enlarged and has an elliptical shape. A device that has a shape. 40. The device of claim 36, wherein said means for relieving said suction force is It consists of a channel extending over the length of the tube. The aforementioned channel is clearly separate and distinct from the aforementioned longitudinal passage within the aforementioned tube and is mutually exclusive. Equipment that does not come in contact with other people. 41. The device of claim 36, wherein said absorption generating means reciprocates within said passageway. having a movable shaft means, said shaft having an inner end and an outer end, said inner end is located closer to said opening means than said outer end and said absorption generating means also has a tip provided on said inner end of said shaft, said tip being said Prevents cervical-vaginal fluid drawn into the passageway from flowing beyond the aforementioned tip location appliance having means for