RU2666604C1 - Method of estimation of acid-base balance of female genital organs (options) - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine, namely to gynecology, and can be used to assess the acid-base balance of female genital organs. To do this, the vaginal mirror and the pH-metric probe are inserted into the vagina. Then the pH is examined and compared with the reference values. In this case, the pH in the region of the external cavity of the uterine neck and in the posterior vault of the vagina is consistently investigated. Method for assessing the acid-base balance of female genital organs, including a study of the pH in the cervical canal and/or in the region of the internal throat and/or pH in the uterine cavity and/or the uterine mucosa, is also provided.

EFFECT: group of inventions allows to more accurately determine the pH of female genital organs for diagnosis and evaluation of the treatment of inflammatory diseases of internal genital organs and for the prediction of the result of in vitro fertilization in women with infertility.

2 cl, 7 tbl, 1 dwg

Description

The present invention relates to obstetrics and gynecology, and in particular to methods for assessing the acid-base condition, and is intended to diagnose and evaluate the outcome of treatment of inflammatory diseases of the internal genital organs, accompanied by the development of local disorders of the acid-base condition (vaginitis, cervicitis, endometritis, etc.), and also to predict the development of female infertility due to intrauterine factors

In medical practice, modern methods of pH metering are used in the diagnosis and treatment of acid-dependent diseases.

Diagnostic pH-metry includes a wide range of possibilities for pH-metric studies: with pH probes and electrodes, 24-hour pH monitoring, short-term pH-metry, pH-metry with endoscopic interventions, etc.

It should be noted that determining the pH of biological fluids of the vagina, uterus, fallopian tubes has not yet become routine.

It has been proven that without pH metering it is impossible to study the microecology of the vagina, given the role of vaginal acidity in maintaining biological homeostasis.

However, a modern diagnosis of vaginal infections is not possible without pH metering.

There is a method for assessing the acid-base state using a simple test called point-of-care (POC), (see the article by II Dementiev, et al. “POINT OF CARE Technologies in the Emergency Clinic” https: / /cyberleninka.ru/article/n/tehnologii-point-of-care-v-klinike-neotlozhnyh-sostoyaniy)

Such tests, for example, are the determination of vaginal pH, the study of a native smear from the vagina.

Thanks to the presence of test systems for independent determination of the pH balance, it became possible to study the acidity of the vaginal fluid not only by the doctor, but also by the patient herself. This test is carried out using paper or plastic litmus test strips with determination of pH level based on color change - pH meter using indicator strips, for example, pHydrion (Lyphan, USA) with a measurement scale from 4.3 to 6.1 and a step of 0 , 4 or a pH indicator (Merck, USA) with the appropriate division from 3.8 to 5.4 and a step of 0.2-0.3.

The disadvantages of this method:

limited use - only for the diagnosis of inflammatory conditions of the vagina, the inability to diagnose diseases of the cervix and uterine cavity,

the impossibility of diagnosing the uterine factor of infertility,

the impossibility of predicting the results of ART, the closest in technical essence to the proposed method for assessing the acid-base condition of female genital organs is a method in which the pH level of the vaginal contents is measured using electrodes attached to a laboratory ionometer (see Gynecology No. 02 2014 - The role of pH -metry in the diagnosis of vaginal infections).

For this, a vaginal mirror is inserted into the vagina, then a pH metric probe is inserted into the vagina, the pH is examined and compared with reference values.

Electrode pH metering was carried out directly during gynecological examination in situ using a glass-calomel electrode, for example, a single-rod combined electrode, in which glass and auxiliary electrodes were combined.

The disadvantages of this method: limited use - only for the diagnosis of inflammatory conditions of the vagina, the inability to diagnose diseases of the cervix and uterine cavity, the inability to diagnose the uterine factor infertility, the inability to predict the results of ART

The technical result solved by the invention is the creation of a method for assessing the acid-base condition of the female genital organs, which allows a more accurate determination of the pH-acidity of the female genital organs for the diagnosis and treatment of inflammatory diseases of the internal genital organs, accompanied by the development of local acid-base disorders ( vaginitis, cervicitis, endometritis, etc.).

The proposed method, when comparing the obtained pH results with reference values, allows us to make a conclusion about the presence of diseases accompanied by local violations of the acid-base state (vaginitis, cervicitis, endometritis, etc.), and also after treatment, after repeated research, evaluate the results of treatment of diseases accompanied by local disorders acid-base condition.

The technical result in the present invention can also be achieved by creating a method for assessing the acid-base condition of female genital organs, including insertion of a vaginal speculum, insertion of a pH-metric probe into the vagina, pH measurement and comparison with reference values, in which, according to the invention, the pH is examined in the cervical canal and / or in the area of the internal pharynx, and / or pH in the uterine cavity, and / or on the uterine mucosa by introducing a pH metric probe into the cervical canal and / or uterine cavity and measuring pH match indications by pH-meter and compared with reference values.

The present invention allows to predict the result of in vitro fertilization (IVF) and embryo transfer (PE) in women with infertility, to determine a woman’s willingness to conduct AI, IVF and PE, as well as to identify risk groups with an ineffective attempt of AI, IVF and PE.

Both versions of the method for assessing the acid-base condition of female genital organs are aimed at obtaining the same technical solution.

The essence of the invention is illustrated by the following description of the method for assessing the acid-base condition of female genital organs and explanatory material, where

In FIG. 1 shows a plot of a reference pH of internal genital organs;

Table 1.- Results of pH-metry of the internal genital organs in volunteers.

Table 3. The pH value of the internal genital organs of patient P.

Table 4. The pH value of the internal genital organs of the patient C. before treatment.

Table 5. The pH value of the internal genital organs of patient C. after treatment.

Table 6. The pH value of the internal Table of the genital organs of patient K. before treatment.

Table 7. The pH value of the internal genital organs of patient K. after treatment.

The essence of the invention is as follows.

Pre-carry out the disinfection and sterilization of the pH meter probe and combine it with a pH meter.

After installing the vaginal speculum and examining the vagina and cervix, the working end of the pH-metric probe with a sensor located on it is inserted into the external pharynx of the cervix. In this case, the sensor abuts against the walls of the external pharynx, making it difficult to advance.

In this position, determine the pH level according to the pH meter. Then the probe is advanced into the cervical canal and there the pH level is determined by the readings of the pH meter.

When moving along the cervical canal, the pH-metric probe does not experience resistance. The next obstacle to the advancement of the probe occurs when it is in contact with the internal pharynx. In this position, the readings of the pH meter are noted.

Then the probe is advanced into the uterine cavity and the pH meter is noted. With further advancement, the probe abuts against the mucous membrane of the uterine fundus. In this position, a pH meter is performed. Then the probe is advanced in the opposite direction, and after removal into the vagina, its sensor is touched to the mucous membrane in the region of the posterior fornix. The pH meter is noted, after which the probe is removed.

First, a reference pH was determined.

23 volunteers (healthy women of childbearing age (21-29 years old) were examined to determine the reference pH values in the female genital organs

In 8 volunteers, studies were performed once, in 15 - 2 or 3 times in different phases of the menstrual cycle. The results of the study are presented in table 1.

The results are processed statistically. The arithmetic mean (expectation - M ₀ ) and standard deviation (σ) were calculated. According to their values, the upper and lower limits of the norm were estimated. The results are presented in table 2 and FIG. one.

Thus, the standard pH values are normal: in the vagina; in the area of the external pharynx; in the cervical canal; in the area of the internal pharynx; in the uterine cavity; on the mucous membranes of the uterus. The pH level depends on the distance from the external pharynx.

The lower limit of the pH is:

in the area of the external pharynx 5.94;

in the cervical canal at a depth of 1 cm from the external pharynx - 6.22,

at a depth of 2 cm - 6.45;

at a depth of 3 cm - 6.70 in the area of the internal pharynx - 6.91;

in the uterine cavity at a depth of 5 cm from the external pharynx - 6.98,

at a depth of 6 cm - 7.03; on the mucous membranes of the uterus - 7.12.

These values are taken as borderline for distinguishing between normal and pathological (inflammatory) diseases of the genital organs, accompanied by the development of local acidosis.

The upper limit of the pH is:

in the vagina - 5.21;

in the area of the external pharynx 6.78;

in the cervical canal at a depth of 1 cm from the external pharynx - 6.88.

These values are taken as borderline for distinguishing between norm and inflammatory diseases of the genital organs (vaginitis, cervicitis of the external throat zone) accompanied by a weakening of local acidosis.

To diagnose diseases accompanied by a violation of the local acid-base state, namely the development of local acidosis (acute and chronic endometritis, cervicitis, etc.), a pH study is performed in the external pharynx and / or in the cervical canal, and / or in the internal pharynx, and / or in the uterine cavity and / or on the uterine mucosa and is compared with reference values.

At a pH level in the uterine cavity at a depth of 5 cm from the external pharynx <6.98, at a depth of 6 cm <7.03; on the uterine mucosa <7.12 make a conclusion about the presence of the inflammatory process of the endometrium.

At a pH level on the vaginal wall> 5.21, a conclusion is made about the presence of vaginitis.

At a pH in the external pharynx region> 6.78 or <5.94; in the cervical canal at a depth of 1 cm from the external pharynx> 6.88 or <6.22, at a depth of 2 cm <6.45; at a depth of 3 cm <6.70; in the area of internal pharynx <6.90 conclude the presence of cervicitis.

In the presence of inflammatory diseases of the vagina, cervix and uterine cavity, a course of therapy is carried out (antibacterial, anti-inflammatory, immunostimulating, etc.).

After the course of treatment, a second study of the acid-base condition of the internal genital organs is performed. According to his indicators, the effectiveness of the treatment is evaluated.

If in any part of the internal genital organs (the vagina, and / or the area of the external pharynx, and / or the cervical canal, and / or the area of the internal pharynx, and / or the uterine cavity, and / or uterine wall), pH values are outside the normal range , a woman is assigned to a group with a high risk of infertility due to intrauterine factors.

In the presence of infertility, in order to determine the woman’s readiness to have an ART program - AI, IVF, PE and predict the outcome of ART, a study of the pH of the internal genital organs is carried out using the described method.

Upon receipt of pH values in the interval between the upper and lower normal limits in the external pharynx, in the cervical canal, in the internal pharynx, in the uterine cavity and on the uterine mucosa, they give a positive prognosis and include the patient in the ART program.

At pH values in the uterine cavity at a depth of 5 cm <6.98; at a depth of 6 cm <7.03; on the mucous membrane of the uterus <7.12 give an unfavorable prognosis of the result of in vitro fertilization (IVF) and, therefore, are not included in the ART program.

In the event that the pH values in the uterine cavity and on the uterine mucosa correspond to the interval between the lower and upper normal limits, and the pH values of the vagina, and / or the area of the external pharynx, and / or cervical canal, and / or the area of the internal pharynx the limits of the norm, give a conclusion about the possible onset of pregnancy.

However, the presence of an inflammatory focus can adversely affect the development of pregnancy. A woman is at risk with an ineffective attempt of AI, IVF and PE.

The practical applicability of the proposed method is proved by the following clinical observations.

1. Patient P., 32 years old, applied to the Center for New Medical Technologies LLC (Tula) in the direction of the Tula Regional Perinatal Center for the ART IVF program with a diagnosis of infertility 1: tubal-peritoneal factor, male factor.

From the anamnesis it is known that since 2011 chronic salpingoophoritis has been ill. On this occasion, periodic courses of conservative outpatient treatment are taking place. In 2015, a tubectomy was performed on both sides, cystectomy, conservative myomectomy for chronic bilateral salpingoophoritis-hydrosalpinx, cysts of the left ovary, uterine fibroids. The last course of conservative treatment in June 2017.

At the time of the appeal does not show complaints, the results of STI research and bacterial culture are negative. Husband has chronic bacterial prostatitis.

On the 17th day of the menstrual cycle, a study was made of the acid-base state of the female genital organs according to the proposed method. The pH values in all departments were within normal limits (table. 3)

According to the results of the study, a positive forecast for the ART program is given. The patient performed induction of superovulation (Gonal 1187, Cetrotide 0.25-2 fl, Ovitrel 250) and a fence of 7 oocytes. Produced by ICSI sperm husband.

During the incubation process, 4 embryos were obtained. On day 5, 2 embryos (1.2AA0) were transferred to the uterine cavity.

On the 11th day after the transfer, the hCG level of blood is 67 PIECES, on the 15th day after the transfer - 595 PIECES.

Ultrasound examination of the pelvic organs on September 17, 2017 revealed a fetal egg with an embryo measuring 15 mm in the uterine cavity.

Conclusion: uterine pregnancy 7-8 weeks. The result of the ART program is positive.

2. Patient S., 31 years old, applied to the Center for New Medical Technologies LLC (Tula) in the direction of the Tula Regional Perinatal Center to perform an ART program with a diagnosis of infertility 1: tubal-peritoneal factor, male factor. From the anamnesis it is known that from the age of 15 he suffers from chronic adnexitis.

In 2016, a bilateral tubectomy was performed for a bilateral hydrosalpinx. In the patient examination program in June 2017.

On the 6th day of the menstrual cycle, the acid-base state of the female genital organs (vagina, cervix, uterine cavity) was studied by the proposed method.

The pH values of the vagina, the area of the external pharynx and the cervical canal at a depth of 1 cm from the external pharynx were above the upper limit of the norm (Table 4).

The patient was diagnosed with vaginitis, cervicitis.

As an additional examination, sowing was performed from the external pharynx of the cervix.

Revealed Staphylococcus epidermidis at a concentration of 10 ³ × mm ³ . The patient was assigned to a group with a possible pregnancy in the ART program.

However, the presence of an inflammatory focus could adversely affect the development of pregnancy. IVF in this situation is considered impractical.

The patient underwent a course of antibacterial and anti-inflammatory therapy (Flemoklav Solutab 1.0 2 times a day for 7 days, candles Metromicon Neo in the vagina 1 candle 2 times a day for 7 days, then candles with Longidaza 1 candle in the vagina overnight 10 days).

After treatment with a control culture from the external throat, pathogenic microflora was not detected.

In the control study of the acid-base condition of the female genital organs according to the proposed method, the pH values in all departments were within normal limits (table. 5)

Since the pH values at all levels began to correspond to normal indicators, the patient was identified in the group of positive prognosis and included in the ART program.

In September 2017, the patient was stimulated with superovulation (Gonal 1075, Cetrotide 0.25 2 fl, Ovitrel 250.0), puncture and 9 oocyte collection. IVF was performed with the husband’s sperm, 7 embryos were received. The transfer of 2 embryos (quality 2AA, 4AA) and cryopreservation of 2 embryos (quality 3BB, 3VA) were performed.

On the 8th day after the transfer of hCG 255 units.

Ultrasound examination of the pelvic organs on September 29, 2017 revealed two fetal eggs 29 × 16 mm and 25 × 15 mm in size with the presence of embryos in the uterine cavity. Conclusion: uterine pregnancy 5-6 weeks dichoric, diamnotic twins. The result of IVF is positive. 3. A 27-year-old patient K. applied to the Center for New Medical Technologies LLC (Tula) in February 2017 in the direction of the Tula Regional Perinatal Center to perform an ART program with a diagnosis of infertility 2: tubal-peritoneal factor.

From the anamnesis it is known that in 2005 the patient had a normal birth. In 2005-2007, 3 medical abortions. In 2012, a laparotomy, left-sided tubotomy for purulent salpingitis, pelvic peritonitis was performed.

In 2013, left-sided salpingo-ovariolysis and salpingo-neostomy for hydrosalpinx were performed.

In 2013, with hysterosalpingography, the fallopian tubes are passable from both sides.

In 2014, ART IVF was performed.

3 oocytes were obtained, 1 embryo was transferred (M4).

IVF result is negative.

An examination at TsNMT LLC in February 2017 revealed ectropion, chronic cervicitis with focal parakeratosis.

Conducted anti-inflammatory therapy and laser photocoagulation of the cervix.

In May 2017, an ultrasound of the pelvic organs revealed an endometrial polyp.

On the 15th day of the menstrual cycle, a study was made of the acid-base state of the female genital organs according to the proposed method. The pH values in all departments were outside the normal range (table. 6)

According to the results of the study, the patient noted the presence of cervicitis and endometritis.

The patient was identified at risk with an unfavorable prognosis of IVF and hysteroscopy with separate diagnostic curettage was recommended.

With hysteroscopy: the uterine cavity is of normal size, the mouth of the fallopian tubes is not peculiar, the walls of the uterus are hyperemic, with the presence of fibrinous plaque, small polypous growths along the front wall. Conclusion: signs of chronic endometritis, endometrial polyposis. Performed curettage of the uterine cavity.

The histological conclusion: chronic endometritis, destroyed glandular-fibrous polyp. According to the results of the study, the patient’s diagnosis was corrected: Infertility 2: tubal-peritoneal factor, uterine factor (chronic endometritis).

The patient underwent a course of conservative therapy (from day 1 of the menstrual cycle - ceftriaxone 1.0+ metrogil 100.0 in / drip 1 r per day for 7 days, ceftriaxone 1.0 in \ m - 7 days.

From the 3rd day of the menstrual cycle, vaginal suppositories with longidase of 1 St. at night - 10 days, tampons with dimexide 1 r per day - 10 days, intracavitary laser therapy or Laser on the uterus area No. 7).

After treatment in August 2017 (on the 16th day of the menstrual cycle, a second study of the acid-base condition of the female genital organs was performed according to the proposed method. The pH readings in all departments came into line with the normal values (Table 7).

The patient was identified in the positive prognosis group and included in the ART program.

In September 2017, superovulation was induced (Gonal 1112.5, Cetrotide 0.25 - 3 fl, Ovitrel) and 5 oocytes were taken. IVF was performed with husband's sperm.

Received 4 embryos (excellent quality). On day 5, 2 embryos were transferred (3 AA, 3 AB). The couple refused to cryopreserve the remaining embryos.

On the 10th day after the transfer, the level of hCG blood is 270 PIECES. 09/19/2017 and ultrasound of the pelvic organs in the uterine cavity revealed a fetal egg 18 × 11 mm in size with the presence of an embryo. Conclusion: uterine pregnancy 4-5 weeks. The result of IVF is positive.

Thus, the proposed method allows you to measure the pH level in the external pharynx, in the cervical canal, in the internal pharynx, in the uterine cavity, on the uterine mucosa, in the vagina; Provides ease of pH measurement in female genital organs.

Table 6. The pH value of the internal genital organs of the patient K. before treatment.

Claims (2)

1. A method for assessing the acid-base condition of female genital organs, including introducing a vaginal specimen, introducing a pH-metric probe into the vagina, examining the pH and comparing it with reference values, characterized in that the pH is sequentially studied in the external pharynx of the cervix and in back arch of the vagina. 2 A method for assessing the acid-base condition of female genital organs, including introducing a vaginal specimen, introducing a pH metric probe into the vagina, examining the pH and comparing it with reference values, characterized in that the pH is examined in the cervical canal and / or in the region of the internal pharynx and / or pH in the uterine cavity and / or on the uterine mucosa by introducing a pH-metric probe into the cervical canal and / or uterine cavity and measuring the pH level according to the pH meter and compared with reference values.

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