Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure

April 27, 2016 updated by: Yunhai Chuai, Navy General Hospital, Beijing

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100048
        • Navy General Hospital
        • Contact:
        • Principal Investigator:
          • Yunhai Chuai, Dr
        • Principal Investigator:
          • Wei Shang, Dr
        • Principal Investigator:
          • Lei Chen, Dr
        • Sub-Investigator:
          • Mingming Shu, Dr
        • Sub-Investigator:
          • Ming Zhou, Dr
        • Sub-Investigator:
          • Mengnan Chen, Dr
        • Sub-Investigator:
          • Huiming Han, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Drospirenone and ethinyl estradiol combination (Yasmin)
Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
multiple pregnancy
Time Frame: 3 years
The condition of carrying two or more FETUSES.
3 years
miscarriage
Time Frame: 3 years
Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.
3 years
clinical pregnancy rate
Time Frame: 3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Investigators

  • Principal Investigator: Wei Shang, Dr, Navy General Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

April 24, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCPOF-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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