Back to resultsThe Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles
Primary Purpose
Infertility
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
human menopausal gonadotropin
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility 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)
Sites / Locations
- Department of Obstetrics and Gynecology, Kasr Al-Ainy hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Human menopausal gonadotropin (HMG)
Routine care
Arm Description
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
This group will receive the routine care for luteal phase support
Outcomes
Primary Outcome Measures
Live birth rate
The live birth rate will be calculated by a statistician for each group
Secondary Outcome Measures
Clinical pregnancy rate
The clinical pregnancy rate will be calculated by a statistician for each group
Implantation rate
The implantation rate will be calculated by a statistician for each group
Miscarriage rate
The miscarriage rate will be calculated by a statistician for each group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03209687
Brief Title
The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles
Official Title
Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Human menopausal gonadotropin (HMG)
Arm Type
Experimental
Arm Description
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
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
This group will receive the routine care for luteal phase support
Intervention Type
Drug
Intervention Name(s)
human menopausal gonadotropin
Other Intervention Name(s)
Merional
Intervention Description
Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles
Primary Outcome Measure Information:
Title
Live birth rate
Description
The live birth rate will be calculated by a statistician for each group
Time Frame
This outcome will be calculated 2 years after enrollment of the first patient in the study
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
The clinical pregnancy rate will be calculated by a statistician for each group
Time Frame
This outcome will be calculated 2 years after enrollment of the first patient in the study
Title
Implantation rate
Description
The implantation rate will be calculated by a statistician for each group
Time Frame
This outcome will be calculated 2 years after enrollment of the first patient in the study
Title
Miscarriage rate
Description
The miscarriage rate will be calculated by a statistician for each group
Time Frame
This outcome will be calculated 2 years after enrollment of the first patient in the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Omran, M.D.
Phone
00223682030
Email
eman.omran@kasralaini.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa Belal, M.D.
Phone
00223682030
Email
doaash@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelmaguid Ramzy, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eman Omran, M.D.
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
City
Cairo
State/Province
Greater Cairo
ZIP/Postal Code
11956
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman Omran, M.D.
Phone
+20223682030
Email
eman.omran@kasralainy.edu.eg
First Name & Middle Initial & Last Name & Degree
Doaa Belal, M.D.
Phone
+20223682030
Email
doaash@live.com
First Name & Middle Initial & Last Name & Degree
Abdelmaguid Ramzy, M.D.
First Name & Middle Initial & Last Name & Degree
Eman Omran, M.D.
First Name & Middle Initial & Last Name & Degree
Doaa Belal, M.D.
12. IPD Sharing Statement
Learn more about this trial
The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles
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