The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

Ovarian Reserve Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03009370
• Other study ID #: KanuniSSSTRH
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2016
• Last updated: December 31, 2016
• Start date: July 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2016
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: Gonca Yetkin Yildirim, MD
• Phone: +90 5323532205
• Email: goncayetkinyildirim[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Miscarriage, Recurrent
• Ovarian Reserve

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Egitim ve Arastirma Hastanesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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):1236-40. doi: 10.1016/j.fertnstert.2016.01.001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ELISA 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	Yes
Secondary	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 . Units 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	Yes