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

NCT02785809 | Unknown

• 1 other identifier: H-16021266
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Oral contraceptives; long-term use; AMH; Ovarian reserve parameters

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Correlation between suppression of the pituitary gonodal axis during use of oral contraceptives and time for recovered menstrual cycle

  3 months

Interventions

Pausing oral contraceptive OTHER

Eligibility Criteria

• Age: 26 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Minimum three years of oral contraceptives.

You may not qualify if:

• Known infertility, known thyroid disease.

Sponsors & Collaborators

• Anders Nyboe Andersen: lead
• Hvidovre University Hospital: collaborator
• Herlev Hospital: collaborator

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet, The Fertility Clinic

Copenhagen, Copenhagen, 2100, Denmark

RECRUITING

Related Publications (3)

• 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.

  PMID: 26584737 BACKGROUND

• van Heusden AM, Fauser BC. Residual ovarian activity during oral steroid contraception. Hum Reprod Update. 2002 Jul-Aug;8(4):345-58. doi: 10.1093/humupd/8.4.345.

  PMID: 12206469 BACKGROUND

• Landersoe SK, Larsen EC, Forman JL, Birch Petersen K, Kroman MS, Frederiksen H, Juul A, Nohr B, Lossl K, Nielsen HS, Nyboe Andersen A. Ovarian reserve markers and endocrine profile during oral contraception: Is there a link between the degree of ovarian suppression and AMH? Gynecol Endocrinol. 2020 Dec;36(12):1090-1095. doi: 10.1080/09513590.2020.1756250. Epub 2020 May 2.

  PMID: 32362164 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Withdrawal of bloodsamples (6 within a three months period) for analyses of reproductive hormones.

Study Officials

• Selma K Landersoe, MD

  Rigshospitalet, The Fertility Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selma K Landersoe, MD

CONTACT

+45 35 45 49 51; selma.kloeve.landersoe.01@regionh.dk

Anders N Andersen, Professor, MD

CONTACT

+45 35 45 13 15; anders.nyboe.andersen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor M.D.

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 30, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 30, 2016

Record last verified: 2016-05

Locations

DK (1)