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Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02757469
Recruitment Status : Not yet recruiting
First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Information provided by (Responsible Party):
Yunhai Chuai, Navy General Hospital, Beijing

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.

Condition or disease Intervention/treatment Phase
Primary Ovarian Insufficiency Menopause, Premature Drug: Drospirenone and ethinyl estradiol combination (Yasmin) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drospirenone and Ethinyl Estradiol Combinations (Yasmin) as Infertility Treatments for Premature Ovarian Failure: a Perspective Follow-up Study.
Study Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

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)

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. multiple pregnancy [ Time Frame: 3 years ]
    The condition of carrying two or more FETUSES.

  3. miscarriage [ Time Frame: 3 years ]
    Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02757469

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Contact: Yunhai Chuai, Dr +86-18810892004

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China, Beijing
Navy General Hospital
Beijing, Beijing, China, 100048
Contact: Yunhai Chuai, Dr    +86-18810892004   
Principal Investigator: Wei Shang, Dr         
Principal Investigator: Lei Chen, Dr         
Principal Investigator: Yunhai Chuai, Dr         
Sub-Investigator: Mingming Shu, Dr         
Sub-Investigator: Ming Zhou, Dr         
Sub-Investigator: Mengnan Chen, Dr         
Sub-Investigator: Huiming Han, Dr         
Sponsors and Collaborators
Navy General Hospital, Beijing
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Principal Investigator: Wei Shang, Dr Navy General Hospital, Beijing
Publications of Results:
Other Publications:
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Responsible Party: Yunhai Chuai, Department of Obstetrics and Gynecology, Navy General Hospital, Beijing, Navy General Hospital, Beijing Identifier: NCT02757469    
Other Study ID Numbers: OCPOF-1
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Drospirenone and ethinyl estradiol combination
Ethinyl Estradiol
Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents