The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

NCT03009370 | Unknown

• 1 other identifier: KanuniSSSTRH
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Reserve; Miscarriage, Recurrent

Keywords

Ovarian reserve, pregnancy loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ovarian reserve tests can be used for the diagnosis of the cause of recurrent pregnancy loss

  up to 6 months

Study Arms (1)

Recurrent miscarriage

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

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Women with RM between 20-40 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, 34325, Turkey (Türkiye)

RECRUITING

Related 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):1236-1240. doi: 10.1016/j.fertnstert.2016.01.001. Epub 2016 Jan 21.

  PMID: 26806685 RESULT

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gonca Yetkin Yıdırım, MD

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Central Study Contacts

Gonca Yetkin Yıldırım, MD

CONTACT

+90 5323532205; goncayetkinyildirim@gmail.com

Nadiye Köroğlu, MD

CONTACT

+90 5058065348; nadiye_dugan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2016
• First Posted: January 4, 2017
• Study Start: July 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: January 4, 2017

Record last verified: 2016-12

Locations

TU (1)