The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

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

Study Overview

• Status: Unknown
• Conditions: Miscarriage, Recurrent; Ovarian Reserve

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

• Study Type: Observational
• Enrollment (Anticipated): 86

Contacts and Locations

• Study Contact: Name: Gonca Yetkin Yıldırım, MD; Phone Number: +90 5323532205; Email: goncayetkinyildirim@gmail.com
• Study Contact Backup: Name: Nadiye Köroğlu, MD; Phone Number: +90 5058065348; Email: nadiye_dugan@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34325
    • Recruiting
    • Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Recurrent miscarriage; RM is defined as three or more pregnancy losses at< 20 weeks of gestation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 . 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	up to 6 months

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Study Director: Gonca Yetkin Yıdırım, MD, Saglik Bilimleri Universitesi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: December 18, 2016
• First Submitted That Met QC Criteria: December 31, 2016
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: December 31, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Ovarian reserve, pregnancy loss
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Habitual
• Other Study ID Numbers: KanuniSSSTRH

Plan for Individual participant data (IPD)

Study Data/Documents

1. Study Protocol