The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

NCT ID: NCT03009370

Last Updated: 2017-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Ovarian Reserve Miscarriage, Recurrent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Recurrent miscarriage

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gonca Yetkin Yildirim

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gonca Yetkin Yıdırım, MD

Role: STUDY_DIRECTOR

Saglik Bilimleri Universitesi

Locations

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Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gonca Yetkin Yıldırım, MD

Role: CONTACT

+90 5323532205

Nadiye Köroğlu, MD

Role: CONTACT

+90 5058065348

References

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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.

Reference Type RESULT
PMID: 26806685 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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KanuniSSSTRH

Identifier Type: -

Identifier Source: org_study_id

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