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

NCT ID: NCT03209687

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-06

Study Completion Date

2024-08-15

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

human menopausal gonadotropin

Intervention Type DRUG

Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles

Routine care

This group will receive the routine care for luteal phase support

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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human menopausal gonadotropin

Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles

Intervention Type DRUG

Other Intervention Names

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Merional

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abdel-Maguid Ramzy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdelmaguid Ramzy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Eman Omran, M.D.

Role: STUDY_DIRECTOR

Cairo University

Locations

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Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman Omran, M.D.

Role: CONTACT

00223682030

Doaa Belal, M.D.

Role: CONTACT

00223682030

Facility Contacts

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Eman Omran, M.D.

Role: primary

+20223682030

Doaa Belal, M.D.

Role: backup

+20223682030

Other Identifiers

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3778

Identifier Type: -

Identifier Source: org_study_id

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