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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human menopausal gonadotropin (HMG) | Experimental | 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 |
|
| Routine care | No Intervention | This group will receive the routine care for luteal phase support |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human menopausal gonadotropin | Drug | Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdelmaguid Ramzy, M.D. | Cairo University | Principal Investigator |
| Eman Omran, M.D. | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital | Cairo | Greater Cairo | 11956 | Egypt |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008596 | Menotropins |
| C527545 | hMG-IBSA |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
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 |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |