Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure
Drospirenone and Ethinyl Estradiol Combinations (Yasmin) as Infertility Treatments for Premature Ovarian Failure: a Perspective Follow-up Study.
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMay 2, 2016
April 1, 2016
4 years
April 24, 2016
April 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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).
3 years
Secondary Outcomes (3)
clinical pregnancy rate
3 years
multiple pregnancy
3 years
miscarriage
3 years
Study Arms (1)
Yasmin
EXPERIMENTALPregnancies 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.
Interventions
Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)
Eligibility Criteria
You may qualify if:
- premature ovarian failure
- normal anatomy
- normal secondary sexual characteristics
- essential or idiopathic
You may not qualify if:
- chromosomal disorder
- iatrogenic injury
- autoimmune diseases
- infection
- genetic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Navy General Hospital
Beijing, Beijing Municipality, 100048, China
Related Publications (2)
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.
PMID: 3080719BACKGROUNDBen-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.
PMID: 24341612RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Shang, Dr
Navy General Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Obstetrics and Gynecology, Navy General Hospital, Beijing
Study Record Dates
First Submitted
April 24, 2016
First Posted
May 2, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2020
Study Completion
May 1, 2021
Last Updated
May 2, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share