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UnknownNCT03009370

The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

Status
Unknown
Phase
Study type
Observational
Enrollment
86 (estimated)
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital · Academic / Other
Sex
Female
Age
20 Years – 40 Years
Healthy volunteers
Accepted

Summary

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

Detailed description

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

Timeline

Start date
2016-07-01
Primary completion
2017-03-01
Completion
2017-03-01
First posted
2017-01-04
Last updated
2017-01-04

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03009370. Inclusion in this directory is not an endorsement.