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

NCT ID: NCT02785809

Last Updated: 2016-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Oral Contraceptives Long-term Use AMH Ovarian Reserve Parameters

Keywords

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Oral contraceptives long-term use AMH Ovarian reserve parameters

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pausing oral contraceptive

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Minimum three years of oral contraceptives.

Exclusion Criteria

* Known infertility, known thyroid disease.
Minimum Eligible Age

26 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role collaborator

Anders Nyboe Andersen

OTHER

Sponsor Role lead

Responsible Party

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Anders Nyboe Andersen

Professor M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Selma K Landersoe, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, The Fertility Clinic

Locations

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Copenhagen University Hospital, Rigshospitalet, The Fertility Clinic

Copenhagen, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Selma K Landersoe, MD

Role: CONTACT

Phone: +45 35 45 49 51

Email: [email protected]

Anders N Andersen, Professor, MD

Role: CONTACT

Phone: +45 35 45 13 15

Email: [email protected]

Facility Contacts

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Anders N Andersen, Professor

Role: primary

Selma K Landersø, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 26584737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12206469 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32362164 (View on PubMed)

Other Identifiers

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H-16021266

Identifier Type: -

Identifier Source: org_study_id