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Purpose of the study is the evaluation of the tolerability (both local and systemic) and the clinical efficacy (in terms oocytes recovered) of subcutaneously versus intramuscularly administered Merional® (IBSA, Lugano - CH) in patients undergoing controlled ovarian hyperstimulation (COH) in an ART programme (IVF).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hMG-IBSA | Drug | |||
| Ovarian stimulation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes recovered |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Day of Oocyte collection, 17β-estradiol Cmax, Total dose of gonadotrophin (IU) or n° of vials and n° of vials/day,Number of mature follicles (follicles ³ 16 mm in diameter) on hCG day (or one day earlier), Clinical pregnancy rate | ||
| Tolerability: Number of Adverse Events (AEs) experienced during the study, Occurrence of Ovarian Hypestimulation Syndrome (OHSS), Local tolerability at the injection site, Haematological-biochemical laboratory tests, before and after treatment, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Ragni, Prof. | Ospedale S.Martino - Genova (Italy) | Principal Investigator |
| Luigi Fedele, Prof. | Ospedale S. Paolo - Milano (Italy) | Principal Investigator |
| Giuseppe De Placido, Prof. | Ospedale Federico II - Napoli (Italy) | Principal Investigator |
| Marco Massobrio, Prof. | Ospedale S. Anna - Torino (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale S. Martino | Genova | Genova | 16132 | Italy | ||
| Ospedale S. Paolo |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C527545 | hMG-IBSA |
| D010062 | Ovulation Induction |
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Milan |
| Milano |
| 20142 |
| Italy |
| Ospedale Federico II | Naples | Napoli | 80131 | Italy |
| Ospedale S. Anna | Torino | Torino | 10126 | Italy |