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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Infertility Drug: human menopausal gonadotropin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT)
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : August 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
Drug Information available for: Menotropins

Arms and Interventions
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Arm Intervention/treatment
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
 Drug: human menopausal gonadotropin
Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles
Other Name: Merional
No Intervention: Routine care
This group will receive the routine care for luteal phase support


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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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): NCT03209687


Contacts
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Contact: Eman Omran, M.D. 00223682030 eman.omran@kasralaini.edu.eg
Contact: Doaa Belal, M.D. 00223682030 doaash@live.com

Locations
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Egypt
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital Recruiting
Cairo, Greater Cairo, Egypt, 11956
Contact: Eman Omran, M.D.    +20223682030    eman.omran@kasralainy.edu.eg   
Contact: Doaa Belal, M.D.    +20223682030    doaash@live.com   
Principal Investigator: Abdelmaguid Ramzy, M.D.         
Sub-Investigator: Eman Omran, M.D.         
Sub-Investigator: Doaa Belal, M.D.         
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Abdelmaguid Ramzy, M.D. Cairo University
Study Director: Eman Omran, M.D. Cairo University
More Information
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Responsible Party: Abdel-Maguid Ramzy, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03209687    
Other Study ID Numbers: 3778
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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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
Additional relevant MeSH terms:
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Infertility
Menotropins
Fertility Agents, Female
 Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs