The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

Kanuni Sultan Suleyman Training and Research Hospital

Status: Unknown

Conditions: Ovarian Reserve; Miscarriage, Recurrent

Study type: Observational

Funder types: Other

Identifiers

NCT03009370

KanuniSSSTRH

Details and patient eligibility

About

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

Full 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

Enrollment: 86 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

86 participants in 1 patient group

Recurrent miscarriage

Description:

RM is defined as three or more pregnancy losses at\< 20 weeks of gestation.