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

AMH Clinical Trial

Official title:

Recovery of Ovarian Function and Reserve Parameters After Discontinuation of Long-term Use of Oral Contraception: Is the Recovery Period Related to AMH?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02785809
• Other study ID #: H-16021266
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2016
• Last updated: May 27, 2016
• Start date: April 2016
• Est. completion date: March 2020

Study information

• Verified date: May 2016
• Source: Rigshospitalet, Denmark
• Contact: Selma K Landersoe, MD
• Phone: +45 35 45 49 51
• Email: selma.kloeve.landersoe.01[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 26 Years to 40 Years

Eligibility

Inclusion Criteria:

• Minimum three years of oral contraceptives.

Exclusion Criteria:

• Known infertility, known thyroid disease.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• AMH
• Long-term Use
• Oral Contraceptives
• Ovarian Reserve Parameters

Intervention

Other:
• Pausing oral contraceptive

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet, The Fertility Clinic	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Anders Nyboe Andersen	Herlev Hospital, Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Alkema L, Chou D, Hogan D, Zhang S, Moller AB, Gemmill A, Fat DM, Boerma T, Temmerman M, Mathers C, Say L; United Nations Maternal Mortality Estimation Inter-Agency Group collaborators and technical advisory group. Global, regional, and national levels and trends in maternal mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Maternal Mortality Estimation Inter-Agency Group. Lancet. 2016 Jan 30;387(10017):462-74. doi: 10.1016/S0140-6736(15)00838-7. Epub 2015 Nov 13. — View Citation

van Heusden AM, Fauser BC. Residual ovarian activity during oral steroid contraception. Hum Reprod Update. 2002 Jul-Aug;8(4):345-58. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for recovered menstrual cycle after discontinuation of oral contraception		6 months after discontinuation	No
Primary	Ovarian reserve parameters before and after discontinuation of combined oral contraception		3 months after discontinuation	No
Secondary	Correlation between suppression of the pituitary gonodal axis during use of oral contraceptives and time for recovered menstrual cycle		3 months	No