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Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure

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ClinicalTrials.gov Identifier: NCT02757469
Recruitment Status : Not yet recruiting
First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
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
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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT02757469


Contacts
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Contact: Yunhai Chuai, Dr +86-18810892004 wangyh85@foxmail.com

Locations
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China, Beijing
Navy General Hospital Not yet recruiting
Beijing, Beijing, China, 100048
Contact: Yunhai Chuai, Dr    +86-18810892004    wangyh85@foxmail.com   
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
Investigators
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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
ClinicalTrials.gov Identifier: NCT02757469     History of Changes
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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Primary Ovarian Insufficiency
Gonadal Dysgenesis
Ovarian Diseases
Urogenital Abnormalities
Congenital Abnormalities
Cardiovascular Abnormalities
Premature Birth
Infertility
Menopause, Premature
Turner Syndrome
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Genital Diseases, Male
Genital Diseases, Female
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Drospirenone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents