Primary Ovarian InsufficiencyNCT02757469
Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure
A study testing Drospirenone and ethinyl estradiol combination (Yasmin) in people with Primary Ovarian Insufficiency and Menopause, Premature, run by Navy General Hospital, Beijing at 1 site in China.
Trial summary
Premature ovarian insufficiency (POI) is a life-changing condition that affects women in their reproductive age. There is a lack of reports which focus on how to improve the reproductive outcome of these women who wish to conceive spontaneously or use assisted conception with their own oocytes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Primary Ovarian Insufficiency, Menopause, Premature
- What is being tested?
- Drospirenone and ethinyl estradiol combination (Yasmin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2016to May 2021
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- premature ovarian failure
- normal anatomy
- normal secondary sexual characteristics
- essential or idiopathic
Who cannot join
- chromosomal disorder
- iatrogenic injury
- autoimmune diseases
- infection
- genetic diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Navy General Hospital
Beijing, Beijing Municipality, 100048
Yunhai Chuai, Dr, +86-18810892004, wangyh85@foxmail.com
Wei Shang, Dr
About this study
Official title: Drospirenone and Ethinyl Estradiol Combinations (Yasmin) as Infertility Treatments for Premature Ovarian Failure: a Perspective Follow-up Study.
Premature ovarian insufficiency (POI) is a life-changing condition that affects women in their reproductive age. There is a lack of reports which focus on how to improve the reproductive outcome of these women who wish to conceive spontaneously or use assisted conception with their own oocytes. However, one could surmise that it is important to lower gonadotropin levels into the physiological range before embarking on any treatment, even if natural conception is the only choice for the woman/couple.
- Being tested
- Drospirenone and ethinyl estradiol combination (Yasmin)
- Medical subject headings
- Primary Ovarian Insufficiency, Menopause, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drospirenone and ethinyl estradiol combination (Yasmin)Drug
Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)
| Study group | Role | What they receive |
|---|---|---|
| Yasmin | Experimental | Pregnancies will occur while the women are taking oral contraceptives (Yasmin). The possible role of exogenous estrogens in sensitizing the granulosa cells to the effect of follicle-stimulating hormone and thereby inducing ovulation and conception in some women with premature ovarian failure is examined. Receives: Drug: Drospirenone and ethinyl estradiol combination (Yasmin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth
The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).
Measured: 3 years
Secondary outcomes (3)
clinical pregnancy rate
The ratio of the number of conceptions (CONCEPTION) including LIVE BIRTH; STILLBIRTH; and fetal losses, to the mean number of females of reproductive age in a population during a set time period.
Measured: 3 years
multiple pregnancy
The condition of carrying two or more FETUSES.
Measured: 3 years
miscarriage
Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Ovarian InsufficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunhai Chuai, Navy General Hospital, Beijing
- Investigators
- Wei Shang, Dr, Principal investigator, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757469
- Sponsor's protocol ID
- OCPOF-1
- Status last verified
- Apr 2016
- First submitted
- 24 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Alper MM, Jolly EE, Garner PR. Pregnancies after premature ovarian failure. Obstet Gynecol. 1986 Mar;67(3 Suppl):59S-62S. doi: 10.1097/00006250-198603001-00018.
PubMed 3080719Ben-Nagi J, Panay N. Premature ovarian insufficiency: how to improve reproductive outcome? Climacteric. 2014 Jun;17(3):242-6. doi: 10.3109/13697137.2013.860115. Epub 2013 Dec 16.
PubMed 24341612
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drospirenone and Ethinyl Estradiol Combinations (Yasmin) as Infertility Treatments for Premature Ovarian Failure: a Perspective Follow-up Study.
- ClinicalTrials.gov ID
- NCT02757469
- Acronym / sponsor ID
- OCPOF-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 2 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.
Premature ovarian insufficiency (POI) is a life-changing condition that affects women in their reproductive age. There is a lack of reports which focus on how to improve the reproductive outcome of these women who wish to conceive spontaneously or use assisted conception with their own oocytes. However, one could surmise that it is important to lower gonadotropin levels into the physiological range before embarking on any treatment, even if natural conception is the only choice for the woman/couple.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yasmin | Experimental | Drug: Drospirenone and ethinyl estradiol combination (Yasmin)Pregnancies will occur while the women are taking oral contraceptives (Yasmin). The possible role of exogenous estrogens in sensitizing the granulosa cells to the effect of follicle-stimulating hormone and thereby inducing ovulation and conception in some women with premature ovarian failure is examined. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- premature ovarian failure
- normal anatomy
- normal secondary sexual characteristics
- essential or idiopathic
Key exclusion criteria (5 listed)
- chromosomal disorder
- iatrogenic injury
- autoimmune diseases
- infection
- genetic diseases
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 |
|---|---|---|
| Drospirenone and ethinyl estradiol combination (Yasmin)Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes) | Drug | Yasmin |
Primary outcome
live birth
Time frame: 3 years
The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).
3 secondary outcomes
clinical pregnancy rate
Time frame: 3 years
multiple pregnancy
Time frame: 3 years
miscarriage
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Background: PubMed 3080719Alper MM, Jolly EE, Garner PR. Pregnancies after premature ovarian failure. Obstet Gynecol. 1986 Mar;67(3 Suppl):59S-62S. doi: 10.1097/00006250-198603001-00018.
- Results publication: PubMed 24341612Ben-Nagi J, Panay N. Premature ovarian insufficiency: how to improve reproductive outcome? Climacteric. 2014 Jun;17(3):242-6. doi: 10.3109/13697137.2013.860115. Epub 2013 Dec 16.
- Individual participant dataSharing planned: Yes
Related trials for Primary Ovarian Insufficiency
RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
RecruitingPhase 3
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Premature Ovarian Insufficiency
RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
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.
Wei Shang, Dr principal investigator
Navy General Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drospirenone and ethinyl estradiol combination (Yasmin) in people with Primary Ovarian Insufficiency and Menopause, Premature, run by Navy General Hospital, Beijing at 1 site in China.
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 4 inclusion and 5 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 2 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 China. 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 Yunhai Chuai, Dr (+86-18810892004, wangyh85@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth (time frame: 3 years). 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 NCT02757469, which also lists 2 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 2 May 2016.