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The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles

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.
 
ClinicalTrials.gov Identifier: NCT03209687
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Abdel-Maguid Ramzy, Cairo University

Tracking Information
First Submitted Date  ICMJE July 4, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE July 6, 2017
Estimated Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
Live birth rate [ Time Frame: This outcome will be calculated 2 years after enrollment of the first patient in the study ]
The live birth rate will be calculated by a statistician for each group
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
  • Clinical pregnancy rate [ Time Frame: This outcome will be calculated 2 years after enrollment of the first patient in the study ]
    The clinical pregnancy rate will be calculated by a statistician for each group
  • Implantation rate [ Time Frame: This outcome will be calculated 2 years after enrollment of the first patient in the study ]
    The implantation rate will be calculated by a statistician for each group
  • Miscarriage rate [ Time Frame: This outcome will be calculated 2 years after enrollment of the first patient in the study ]
    The miscarriage rate will be calculated by a statistician for each group
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 The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles
Official Title  ICMJE Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT)
Brief Summary The aim of this study is to test the hypothesis that addition of daily small dose of human menopausal gonadotropin (HMG) drug following oocytes retrieval could improve the fertility outcome in women undergoing in-vitro fertilization
Detailed Description The study will be conducted in the IVF unit of Cairo University. Females undergoing ICSI cycles in the age between 20 and 40 years will be allocated to one of 2 groups. Long agonist protocol will be used. Allocation to either one of 2 groups will be done on the day of oocytes retrieval. The first group will take (in addition to the routine care) daily human menopausal gonadotropin drug injection for 2 weeks. The second group will receive the routine care.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE Drug: human menopausal gonadotropin
Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles
Other Name: Merional
Study Arms  ICMJE
  • Experimental: Human menopausal gonadotropin (HMG)
    This group will take daily subcutaneous 75 IU (international unit) of human menopausal gonadotropin (HMG) in addition to the usual luteal phase support from the day of ovum pickup and will be continued for 2 weeks
    Intervention: Drug: human menopausal gonadotropin
  • No Intervention: Routine care
    This group will receive the routine care for luteal phase support
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2017)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2020
Estimated Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females undergoing Intra-Cytoplasmic Sperm Injection (ICSI) cycles
  • Age between 20 and 40 years

Exclusion Criteria:

  • Females who have high response (estradiol at time of ovulation trigger is > 5000 pg/ml or more than 15 oocytes are retrieved)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eman Omran, M.D. 00223682030 eman.omran@kasralaini.edu.eg
Contact: Doaa Belal, M.D. 00223682030 doaash@live.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03209687
Other Study ID Numbers  ICMJE 3778
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abdel-Maguid Ramzy, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abdelmaguid Ramzy, M.D. Cairo University
Study Director: Eman Omran, M.D. Cairo University
PRS Account Cairo University
Verification Date July 2019

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