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This study is intended for women undergoing their first cycle of 3 intrauterine inseminations. All 3 inseminations will be personalized by using algorithms to determine the dose of study medication.
Study medication dosage for the first insemination cycle will be based on the woman's age as well as her Anti-Mullerian Hormone (AMH) levels.
Study medication dosage for the second and third insemination will depend on ovarian response (number of follicles) during previous insemination cycle and woman's age
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rekovelle (Follitropin delta) | Other | All participants will receive a prescription for study medication Rekovelle (follitropin delta) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follitropin delta | Drug | Study medication doses during all 3 insemination will be personalized using a suggested algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian response | Evaluate the dose-response Relationship of Rekovelle with respect to ovarian response in participants undergoing controlled ovarian stimulation for intrauterine insemination | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Fertile women undergoing intrauterine insemination
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Kadoch, MD | Clinique Ovo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Ovo | Montreal | Quebec | H4P 2S4 | Canada |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000620228 | follitropin delta |
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open-label, prospective, dose-finding, single centre pilot study.
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