A multicenter observational study to determine relation between different factors that may affect the ovarian reserve in infertile women in selected centers in India

Not Applicable

Completed

• Conditions: Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

• Registration Number: CTRI/2018/12/016772
• Lead Sponsor: The Federation of Obstetric Gynecological Society of India FOGSI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-10-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 423

Inclusion Criteria

1.Females between 18 and 45 years of age;

2.Not attained menopause;

3.Not able to conceive in last 12 months (at time of study consent) after unprotected sexual intercourse;

4.Regular menstrual cycles with cycle length of 25-35 days with <= 4 days difference between cycles;

5.Presence of both ovaries;

6.Willing and able to sign the study informed consent form

Exclusion Criteria

1.Presence of gynecological disorders such as menorrhagia or dysfunctional uterine bleeding;

2.History of ovarian surgery;

3.History of taking injectable hormonal contraception in the preceding year or hormonal therapy/herbal product within 12 months prior to most recent AMH or AFC test

4.Irregular menstruation (interval: less than 21 days or more than 45 days);

5.History of Hypertension (controlled or uncontrolled);

6.Malignancy or exposure to cytotoxic drugs and pelvic radiotherapy, endocrinological disorders, including abnormal prolactin, TSH or diabetes

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure for the study is to determine the correlation between biomarkers of ovarian reserve (AMH and AFC) and physical characteristic like age, BMI, occupational exposures (moving or lifting heavy objects, level of physical exertion and typical work shift), age of menarche, and menstrual cycle length.Timepoint: At the time of diagnosis of Infertility

Secondary Outcome Measures

Name	Time	Method
o secondary end pointTimepoint: Not Applicable