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The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03009370
Collaborator
(none)
86
Enrollment
1
Location
8
Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    86 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Study Start Date :
    Jul 1, 2016
    Anticipated Primary Completion Date :
    Mar 1, 2017
    Anticipated Study Completion Date :
    Mar 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Recurrent miscarriage

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

    Outcome Measures

    Primary Outcome Measures

    1. The effect of the ovarian reserve on the recurrent pregnancy loss [up to 6 months]

      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.

    Secondary Outcome Measures

    1. Ovarian reserve tests can be used for the diagnosis of the cause of recurrent pregnancy loss [up to 6 months]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi Istanbul Turkey 34325

    Sponsors and Collaborators

    • Kanuni Sultan Suleyman Training and Research Hospital

    Investigators

    • Study Director: Gonca Yetkin Yıdırım, MD, Saglik Bilimleri Universitesi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gonca Yetkin Yildirim, MD, Kanuni Sultan Suleyman Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT03009370
    Other Study ID Numbers:
    • KanuniSSSTRH
    First Posted:
    Jan 4, 2017
    Last Update Posted:
    Jan 4, 2017
    Last Verified:
    Dec 1, 2016
    Keywords provided by Gonca Yetkin Yildirim, MD, Kanuni Sultan Suleyman Training and Research Hospital
    Ovarian reserve, pregnancy loss
    Additional relevant MeSH terms:
    Abortion, Spontaneous
    Abortion, Habitual

    Study Results

    No Results Posted as of Jan 4, 2017