Oral ContraceptivesNCT02785809
Ovarian Function and Reserve Parameters After Discontinuation of Long-term Use of Oral Contraception
An observational study of Oral Contraceptives and Long-term Use, run by Anders Nyboe Andersen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Contraceptives, Long-term Use, AMH
- What is being tested?
- Pausing oral contraceptive
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2016to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with a history of long term use of combine oral contraception for at least 3 years.
Who may be able to join
- Minimum three years of oral contraceptives.
Who cannot join
- Known infertility, known thyroid disease.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Rigshospitalet, The Fertility Clinic
Copenhagen, Copenhagen, 2100
Anders N Andersen, Professor, +4535451315, anders.nyboe.andersen@regionh.dk
Selma K Landersø, MD, +45 3545 4951, selma.kloeve.landersoe.01@regionh.dk
About this study
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?
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.
Read the 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.
- Conditions
- Oral Contraceptives, Long-term Use, AMH, Ovarian Reserve Parameters
- Being tested
- Pausing oral contraceptive
- Keywords
- Oral contraceptives, long-term use, AMH, Ovarian reserve parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pausing oral contraceptiveOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for recovered menstrual cycle after discontinuation of oral contraception
Measured: 6 months after discontinuation
Ovarian reserve parameters before and after discontinuation of combined oral contraception
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral ContraceptivesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anders Nyboe Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Herlev Hospital
- Responsible party
- Sponsor-investigator, Anders Nyboe Andersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Selma K Landersoe, MD, Principal investigator, Rigshospitalet, The Fertility Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785809
- Sponsor's protocol ID
- H-16021266
- Status last verified
- May 2016
- First submitted
- 25 May 2016
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26584737van 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.
PubMed 12206469Landersoe 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.
PubMed 32362164
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02785809
- Acronym / sponsor ID
- H-16021266
- Conditions
- Oral Contraceptives, Long-term Use, AMH, Ovarian Reserve Parameters
- Keywords
- Oral contraceptives, long-term use, AMH, Ovarian reserve parameters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Anders Nyboe AndersenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Herlev Hospital
- Study start
- Apr 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 26 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with a history of long term use of combine oral contraception for at least 3 years.
Key inclusion criteria (1 listed)
- Minimum three years of oral contraceptives.
Key exclusion criteria (1 listed)
- Known infertility, known thyroid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pausing oral contraceptive | Other | – |
Primary outcome
Time for recovered menstrual cycle after discontinuation of oral contraception
Time frame: 6 months after discontinuation
Ovarian reserve parameters before and after discontinuation of combined oral contraception
Time frame: 3 months after discontinuation
1 secondary outcome
Correlation between suppression of the pituitary gonodal axis during use of oral contraceptives and time for recovered menstrual cycle
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
- Background: PubMed 26584737Alkema 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.
- Background: PubMed 12206469van 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.
- Derived from this study: PubMed 32362164Landersoe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selma K Landersoe, MD principal investigator
Rigshospitalet, The Fertility Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Contraceptives and Long-term Use, run by Anders Nyboe Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selma K Landersoe, MD (+45 35 45 49 51, selma.kloeve.landersoe.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for recovered menstrual cycle after discontinuation of oral contraception (time frame: 6 months after discontinuation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02785809, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.