Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure
Primary Purpose
Primary Ovarian Insufficiency, Menopause, Premature
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drospirenone and ethinyl estradiol combination (Yasmin)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Ovarian Insufficiency
Eligibility Criteria
Inclusion Criteria:
- premature ovarian failure
- normal anatomy
- normal secondary sexual characteristics
- essential or idiopathic
Exclusion Criteria:
- chromosomal disorder
- iatrogenic injury
- autoimmune diseases
- infection
- genetic diseases
Sites / Locations
- Navy General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yasmin
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
multiple pregnancy
The condition of carrying two or more FETUSES.
miscarriage
Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.
Full Information
NCT ID
NCT02757469
First Posted
April 24, 2016
Last Updated
April 27, 2016
Sponsor
Navy General Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT02757469
Brief Title
Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure
Official Title
Drospirenone and Ethinyl Estradiol Combinations (Yasmin) as Infertility Treatments for Premature Ovarian Failure: a Perspective Follow-up Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navy General Hospital, Beijing
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ovarian Insufficiency, Menopause, Premature
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yasmin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Drospirenone and ethinyl estradiol combination (Yasmin)
Intervention Description
Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)
Primary Outcome Measure Information:
Title
live birth
Description
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).
Time Frame
3 years
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
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.
Time Frame
3 years
Title
multiple pregnancy
Description
The condition of carrying two or more FETUSES.
Time Frame
3 years
Title
miscarriage
Description
Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
premature ovarian failure
normal anatomy
normal secondary sexual characteristics
essential or idiopathic
Exclusion Criteria:
chromosomal disorder
iatrogenic injury
autoimmune diseases
infection
genetic diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunhai Chuai, Dr
Phone
+86-18810892004
Email
wangyh85@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Shang, Dr
Organizational Affiliation
Navy General Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Navy General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunhai Chuai, Dr
Phone
+86-18810892004
Email
wangyh85@foxmail.com
First Name & Middle Initial & Last Name & Degree
Wei Shang, Dr
First Name & Middle Initial & Last Name & Degree
Lei Chen, Dr
First Name & Middle Initial & Last Name & Degree
Yunhai Chuai, Dr
First Name & Middle Initial & Last Name & Degree
Mingming Shu, Dr
First Name & Middle Initial & Last Name & Degree
Ming Zhou, Dr
First Name & Middle Initial & Last Name & Degree
Mengnan Chen, Dr
First Name & Middle Initial & Last Name & Degree
Huiming Han, Dr
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
3080719
Citation
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.
Results Reference
background
PubMed Identifier
24341612
Citation
Ben-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.
Results Reference
result
Learn more about this trial
Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure
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