Clinical trial NCT02785809: Ovarian Function and Reserve Parameters After Discontinuation of Long-term Use of Oral Contraception
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Contraceptives
Long-term Use
AMH
Ovarian Reserve Parameters
Keywords: Oral contraceptives
long-term use
AMH
Ovarian reserve parameters
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: Herlev Hospital
First posted: 2016-05-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 26
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a history of long term use of combine oral contraception for at least 3 years.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Minimum three years of oral contraceptives.

Exclusion Criteria:

* Known infertility, known thyroid disease.

Primary outcomes:
measure: Time for recovered menstrual cycle after discontinuation of oral contraception
timeFrame: 6 months after discontinuation
measure: Ovarian reserve parameters before and after discontinuation of combined oral contraception
timeFrame: 3 months after discontinuation
Secondary outcomes:
measure: Correlation between suppression of the pituitary gonodal axis during use of oral contraceptives and time for recovered menstrual cycle
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet, The Fertility Clinic
Study officials:
affiliation: Rigshospitalet, The Fertility Clinic
name: Selma K Landersoe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.