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

Study Overview
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: human menopausal gonadotropin


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human menopausal gonadotropin (HMG)<br>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<br>* Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles<br>* Other names: Merional;|
| No Intervention: Routine care<br>This group will receive the routine care for luteal phase support | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | 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 | 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 | 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 | 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 |