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

February 8, 2023 updated by: Abdel-Maguid Ramzy, Cairo University

Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Greater Cairo
      • Cairo, Greater Cairo, Egypt, 11956
        • Recruiting
        • Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abdelmaguid Ramzy, M.D.
        • Sub-Investigator:
          • Eman Omran, M.D.
        • Sub-Investigator:
          • Doaa Belal, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Merional
NO_INTERVENTION: Routine care
This group will receive the routine care for luteal phase support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
This outcome will be calculated 2 years after enrollment of the first patient in the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
This outcome will be calculated 2 years after enrollment of the first patient in the study
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
This outcome will be calculated 2 years after enrollment of the first patient in the study
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
This outcome will be calculated 2 years after enrollment of the first patient in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Abdelmaguid Ramzy, M.D., Cairo University
  • Study Director: Eman Omran, M.D., Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2017

Primary Completion (ANTICIPATED)

July 15, 2024

Study Completion (ANTICIPATED)

August 15, 2024

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (ACTUAL)

July 6, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3778

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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