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The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

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ClinicalTrials.gov Identifier: NCT03009370
Recruitment Status : Unknown
Verified December 2016 by Gonca Yetkin Yildirim, Kanuni Sultan Suleyman Training and Research Hospital.
Recruitment status was:  Recruiting
First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Gonca Yetkin Yildirim, Kanuni Sultan Suleyman Training and Research Hospital

Study Description
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Brief Summary:
The purpose of this study is to determine whether ovarian reserve is related to recurrent pregnancy loss

Condition or disease
Ovarian Reserve Miscarriage, Recurrent

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
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Study Type : Observational
Estimated Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : July 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

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


Outcome Measures
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Primary Outcome Measures :
  1. The effect of the ovarian reserve on the recurrent pregnancy loss [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009370


Contacts
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Contact: Gonca Yetkin Yıldırım, MD +90 5323532205 goncayetkinyildirim@gmail.com
Contact: Nadiye Köroğlu, MD +90 5058065348 nadiye_dugan@hotmail.com

Locations
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Turkey
Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi Recruiting
Istanbul, Turkey, 34325
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
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Study Director: Gonca Yetkin Yıdırım, MD Saglik Bilimleri Universitesi
More Information
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Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Gonca Yetkin Yildirim, MD, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03009370    
Other Study ID Numbers: KanuniSSSTRH
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016
Keywords provided by Gonca Yetkin Yildirim, Kanuni Sultan Suleyman Training and Research Hospital:
Ovarian reserve, pregnancy loss
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications