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Trial record 28 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing

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

Tracking Information
First Submitted Date  ICMJE April 24, 2016
First Posted Date  ICMJE May 2, 2016
Last Update Posted Date May 2, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2016)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2016)
  • 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.
  • multiple pregnancy [ Time Frame: 3 years ]
    The condition of carrying two or more FETUSES.
  • miscarriage [ Time Frame: 3 years ]
    Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure
Official Title  ICMJE Drospirenone and Ethinyl Estradiol Combinations (Yasmin) as Infertility Treatments for Premature Ovarian Failure: a Perspective Follow-up Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Ovarian Insufficiency
  • Menopause, Premature
Intervention  ICMJE Drug: Drospirenone and ethinyl estradiol combination (Yasmin)
Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)
Study Arms  ICMJE 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.
Intervention: Drug: Drospirenone and ethinyl estradiol combination (Yasmin)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yunhai Chuai, Dr +86-18810892004 wangyh85@foxmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02757469
Other Study ID Numbers  ICMJE OCPOF-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Yunhai Chuai, Navy General Hospital, Beijing
Study Sponsor  ICMJE Navy General Hospital, Beijing
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei Shang, Dr Navy General Hospital, Beijing
PRS Account Navy General Hospital, Beijing
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP