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

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ClinicalTrials.gov Identifier: NCT02785809
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : May 30, 2016
Sponsor:
Collaborators:
Hvidovre University Hospital
Herlev Hospital
Information provided by (Responsible Party):
Anders Nyboe Andersen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment
Oral Contraceptives Long-term Use AMH Ovarian Reserve Parameters Other: Pausing oral contraceptive

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
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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?
Study Start Date : April 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control




Primary Outcome Measures :
  1. Time for recovered menstrual cycle after discontinuation of oral contraception [ Time Frame: 6 months after discontinuation ]
  2. Ovarian reserve parameters before and after discontinuation of combined oral contraception [ Time Frame: 3 months after discontinuation ]

Secondary Outcome Measures :
  1. Correlation between suppression of the pituitary gonodal axis during use of oral contraceptives and time for recovered menstrual cycle [ Time Frame: 3 months ]

Biospecimen Retention:   Samples Without DNA
Withdrawal of bloodsamples (6 within a three months period) for analyses of reproductive hormones.


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Ages Eligible for Study:   26 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with a history of long term use of combine oral contraception for at least 3 years.
Criteria

Inclusion Criteria:

  • Minimum three years of oral contraceptives.

Exclusion Criteria:

  • Known infertility, known thyroid disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785809


Contacts
Contact: Selma K Landersoe, MD +45 35 45 49 51 selma.kloeve.landersoe.01@regionh.dk
Contact: Anders N Andersen, Professor, MD +45 35 45 13 15 anders.nyboe.andersen@regionh.dk

Locations
Denmark
Copenhagen University Hospital, Rigshospitalet, The Fertility Clinic Recruiting
Copenhagen, Denmark, 2100
Contact: Anders N Andersen, Professor    +4535451315    anders.nyboe.andersen@regionh.dk   
Contact: Selma K Landersø, MD    +45 3545 4951    selma.kloeve.landersoe.01@regionh.dk   
Principal Investigator: Selma K Landersoe, MD         
Sub-Investigator: Anders N Andersen, Professor         
Sponsors and Collaborators
Anders Nyboe Andersen
Hvidovre University Hospital
Herlev Hospital
Investigators
Principal Investigator: Selma K Landersoe, MD Rigshospitalet, The Fertility Clinic

Publications:
Responsible Party: Anders Nyboe Andersen, Professor M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02785809     History of Changes
Other Study ID Numbers: H-16021266
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Anders Nyboe Andersen, Rigshospitalet, Denmark:
Oral contraceptives
long-term use
AMH
Ovarian reserve parameters

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female