Clinical trial NCT03009370: The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Reserve
Miscarriage, Recurrent
Keywords: Ovarian reserve, pregnancy loss
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 86
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Recurrent miscarriage is defined as three or more pregnancy loss at\<20 weeks of gestation.The women between 20 -40 years old with history of RM are recruited.

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: The effect of the ovarian reserve on the recurrent pregnancy loss
timeFrame: up to 6 months
Secondary outcomes:
measure: Ovarian reserve tests can be used for the diagnosis of the cause of recurrent pregnancy loss
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Gonca Yetkin Yıdırım, MD
role: STUDY_DIRECTOR
References:
citation: Atasever M, Soyman Z, Demirel E, Gencdal S, Kelekci S. Diminished ovarian reserve: is it a neglected cause in the assessment of recurrent miscarriage? A cohort study. Fertil Steril. 2016 May;105(5):1236-1240. doi: 10.1016/j.fertnstert.2016.01.001. Epub 2016 Jan 21.