Ovarian Function and Reserve Parameters After Discontinuation of Long-term Use of Oral Contraception

• Conditions: Long-term Use; AMH; Ovarian Reserve Parameters; Oral Contraceptives

• Registration Number: NCT02785809
• Lead Sponsor: Anders Nyboe Andersen

Brief Summary

The aim of this study is to investigate whether there is a correlation between anti-Müllerian hormone during long-term use of combined oral contraceptives and the recovery time before recovered menstrual cycle after discontinuation of oral contraceptives.

Detailed Description

Background:

Hormonal contraception is widely used among women worldwide; 50-89% of all women in the Western countries use oral contraception at some point in their lives. Oral contraceptives (OC) suppress the hypothalamic-pituitary-ovarian axis through a negative feedback of ethinyl estradiol and progestins and thereby potentially influence the markers of ovarian reserve due to a suppressed release of gonadotropins, which will impair the growth of antral follicles.

Methods and Materials:

Participants for this studies will be included through the Fertility Assessment and Counseling Clinic, Rigshospitalet, Herlev- and Hvidovre Hospital.

Inclusion criteria: Use of oral contraception (for study 3 at least during the last three years).

Exclusion criteria: Known infertility, known thyroid disease.

Aims:

Study 3: Investigate the ovarian reserve markers after discontinuation of OC over a period of three months in women with a history of long-term OC use. The women will be followed with serial ultrasounds and blood samples and will complete a menstrual calendar.

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-27
• Last Update Submitted: 2016-05-27
• Study First Posted: 2016-05-30
• Last Update Posted: 2016-05-30
• Primary Completion: 2019-05
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Minimum three years of oral contraceptives.

Exclusion Criteria

• Known infertility, known thyroid disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time for recovered menstrual cycle after discontinuation of oral contraception	6 months after discontinuation
Ovarian reserve parameters before and after discontinuation of combined oral contraception	3 months after discontinuation

Secondary Outcome Measures

Name	Time	Method
Correlation between suppression of the pituitary gonodal axis during use of oral contraceptives and time for recovered menstrual cycle	3 months

Trial Locations

Locations (1)

Copenhagen University Hospital, Rigshospitalet, The Fertility Clinic; 🇩🇰 Copenhagen, Denmark