Clinical Trial: The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational




Official Title:

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

Detailed Summary:

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


Sponsor: Kanuni Sultan Suleyman Training and Research Hospital




Current Primary Outcome: The effect of the ovarian reserve on the recurrent pregnancy loss [ Time Frame: up to 6 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Ovarian reserve tests can be used for the diagnosis of the cause of recurrent pregnancy loss [ Time Frame: up to 6 months ]

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


Original Secondary Outcome: Same as current

Information By: Kanuni Sultan Suleyman Training and Research Hospital




Dates:
Date Received: December 18, 2016
Date Started: July 2016
Date Completion: March 2017
Last Updated: December 31, 2016
Last Verified: December 2016