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

May 27, 2016 updated by: Anders Nyboe Andersen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Copenhagen University Hospital, Rigshospitalet, The Fertility Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Selma K Landersoe, MD
        • Sub-Investigator:
          • Anders N Andersen, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with a history of long term use of combine oral contraception for at least 3 years.

Description

Inclusion Criteria:

  • Minimum three years of oral contraceptives.

Exclusion Criteria:

  • Known infertility, known thyroid disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time for recovered menstrual cycle after discontinuation of oral contraception
Time Frame: 6 months after discontinuation
6 months after discontinuation
Ovarian reserve parameters before and after discontinuation of combined oral contraception
Time Frame: 3 months after discontinuation
3 months after discontinuation

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between suppression of the pituitary gonodal axis during use of oral contraceptives and time for recovered menstrual cycle
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anders Nyboe Andersen

Collaborators

Hvidovre University Hospital
Herlev Hospital

Investigators

  • Principal Investigator: Selma K Landersoe, MD, Rigshospitalet, The Fertility Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

May 30, 2016

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

May 27, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16021266

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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