The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

Study Overview
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Brief Summary
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The purpose of this study is to determine whether ovarian reserve is related to recurrent pregnancy loss

Detailed Description
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This study will be conducted at the gynecology and infertility department of Kanuni Sultan Süleyman Training and Research Hospital from 2016 to 2017. The approval of the local Institutional Review Board (KAEK/2016.22.31) was obtained in June 2016 and informed consents of all subjects have been prepared. RM is defined as three or more pregnancy losses at <20 weeks of gestation or fetal weight <500 g. Women with history of RM for whom routine workup for RM (chromosomal analyses of both partners; levels of prolactin and TSH; anticardiolipin antibody, lupus anticoagulant, antinuclear antibody, and coagulation studies; and pelvic ultrasonography) is negative are assigned to the RM group. The control group consists of healthy women with no history of RM who are seeking contraception in the center's family planning unit. To keep the power of the study at 80% with an alpha-level of 0.05, a sample size of minumum 60 patients in each group was required. Demographic data (age,gravidity,parity,pregnancy loss,bmı) ovarian reserve parameters(AMH,FSH,LH,E2,AFC) will be recorded and then two groups will be compared. Data will be analyzed with the use of medcalc version 16.4.8 by Gökhan Yıldırım. Mean,median,SD,lowest and highest frequency ,and ratio values are used at statistical complementary of data .Quantitative data will be analyzed with the use of the Student t test and the Mann-Whitney U test. A chisquare test will be used for analyses of qualitative data

Conditions
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Ovarian Reserve, Miscarriage, Recurrent

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with RM between 20-40 years old Exclusion Criteria: Anovulation or PCOS Presence of endometrosis by laparoscopy or ultrasonography History of ovarian surgery Tobacco use Systemic chemotherapy Pelvic irradition Genetic abnormalities Irregular menstruel cycle family history of premature ovarian failure

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recurrent miscarriage<br>RM is defined as three or more pregnancy losses at< 20 weeks of gestation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of the ovarian reserve on the recurrent pregnancy loss | Venous blood samples will be taken from the antecubital regions of all patients between 8:00 a.m and 9:00 a.m during the early follicular phase (days 2-4) of the menstrual cycle .Serum samples will be stored at -80C and assayed for FSH,LH,E2 and AMH .FSH levels are analyzed by means of an electrochemiluminescence method .The normal range for FSH is 2.5-10 U/L at the early follicular phase. Serum AMH levels will be measured with the use of a human ELİSA kit . The normal range for this assay is 0.05-1.5 ng/ml.In the same morning that the blood tests are performed , the total number of antral follicles measuring 2-10 mm in diameter are evaluated by the operator.A 7.5 -MHz transvaginal probe is used in all examinations.Data will be analyzed with the use of medcalc. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian reserve tests can be used for the diagnosis of the cause of recurrent pregnancy loss | FSH,LH,E2,AMH assesment of at least 86 patients will be analyzed with the use of medcalc . Unıts of measure of FSH,LH,E2 levels are assesed by U/L. The normal range of AMH level is 0.05-1.5ng/ml. Mean ,median ,SD, lowest and highest frequency ,and ratio values are used at statistical complemantary data.Quantitative data are analyzed with the use of the student -t test and Mann-Whitney U test | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian reserve, pregnancy loss