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Trial record 88 of 101 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

Miniflare Versus Long Protocol in Poor Responders

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ClinicalTrials.gov Identifier: NCT02681536
Recruitment Status : Unknown
Verified March 2016 by Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt.
Recruitment status was:  Recruiting
First Posted : February 12, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt

Tracking Information
First Submitted Date  ICMJE February 9, 2016
First Posted Date  ICMJE February 12, 2016
Last Update Posted Date April 4, 2016
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
Number of oocytes retrieved [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02681536 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Miniflare Versus Long Protocol in Poor Responders
Official Title  ICMJE Not Provided
Brief Summary The study is performed to compare the outcomes of two stimulation protocols, the minidose long protocol versus the microdose flare protocol in poor responders undergoing IVF/ICSI.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Triptorelin
    Other Name: Decapeptyl
  • Drug: Combined oral contraceptive pills
    Other Name: Yasmin
  • Drug: HMG
    Other Name: merional
Study Arms  ICMJE
  • Experimental: Minidose long protocol
    Down-regulation started on day 20 of the previous cycle by GnRH agonist triptorelin (0.5 µg Decapeptyl; Ferring). On the second day of menstruation, when down regulation was confirmed (as evidenced by endometrial thickness <5 mm and/or E2 levels <50 pg/mL) using transvaginal sonography (TVS) by Voluson 730 Pro (GE, Fairfield, CT) apparatus, gonadotropin (Merional; IBSA) was commenced at an initial dose of 300-450 IU/day for the first 5 days followed by individual adjustment in Gn dose according to ovarian response and the dose of Decapeptyl 50µg/day was continued until day of HCG administration.
    Interventions:
    • Drug: Triptorelin
    • Drug: HMG
  • Experimental: microdose flare protocol
    OCPs drospirenone /ethinyl estradiol (Yasmin, BAYER) for not less than 21 days before starting ovarian stimulation, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by HMG IM daily (Merional, 75 IU, IBSA) 3 days later. Then the same cycle adjustment was done as the minidose long protocol.
    Interventions:
    • Drug: Triptorelin
    • Drug: Combined oral contraceptive pills
    • Drug: HMG
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 9, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • poor responder women who fulfilled the criteria defined by the ESHRE consensus in 2011[4]; Poor responder females are those who possess two out of these three criteria: i) Female age ≥40 years; ii) Females who have at least one previous cancelled IVF cycle; iii) POR according to AFC ≤5 or low AMH value.

Exclusion Criteria:

  • females with FSH more than 20 IU/L
  • females with previous ovarian surgery
  • females suffering from causes of infertility other than poor ovarian response, cases with polycystic ovaries syndrome
  • females refusing to be enrolled in the study, females with any endocrine disorder such as: diabetes, thyroid
  • patients with male factor of infertility.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02681536
Other Study ID Numbers  ICMJE FS090216
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
Study Sponsor  ICMJE Woman's Health University Hospital, Egypt
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dina MR Dakhly, MD Cairo University
PRS Account Woman's Health University Hospital, Egypt
Verification Date March 2016

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