Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure

NCT ID: NCT02757469

Last Updated: 2016-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Ovarian Insufficiency Menopause, Premature

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Drospirenone and ethinyl estradiol combination (Yasmin)

Intervention Type DRUG

Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)

Interventions

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Drospirenone and ethinyl estradiol combination (Yasmin)

Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Navy General Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Yunhai Chuai

Department of Obstetrics and Gynecology, Navy General Hospital, Beijing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Shang, Dr

Role: PRINCIPAL_INVESTIGATOR

Navy General Hospital, Beijing

Locations

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Navy General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Yunhai Chuai, Dr

Role: CONTACT

+86-18810892004

Facility Contacts

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Yunhai Chuai, Dr

Role: primary

+86-18810892004

References

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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.

Reference Type BACKGROUND
PMID: 3080719 (View on PubMed)

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.

Reference Type RESULT
PMID: 24341612 (View on PubMed)

Other Identifiers

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OCPOF-1

Identifier Type: -

Identifier Source: org_study_id

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