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| Name | Class |
|---|---|
| Create Fertility Center | OTHER |
| Olive Fertility Centre | OTHER |
| Hannam Fertility Centre | UNKNOWN |
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This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in a "mixed protocol" regimen, using an individualized, fixed dose of follitropin delta based on the established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve.
The initial dose of follitropin delta will be determined at enrolment by the analysis of serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body weight in Kg The initial dose of HP-hMG to be added on top of follitropin delta will be determined at enrolment by the total follitropin delta dose and body weight in Kg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follitropin delta and HP-hMG | Experimental | Follitropin delta combined with highly purified human menopausal gonadotrophin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follitropin delta and HP-hMG | Combination Product | Follitropin delta dose will be determined by AMG and weight in Kg. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight in Kg |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture | Utilizable blastocyst is defined as embryo at day 5 or 6 suitable for transfer | 6 days of embryo culture |
| Measure | Description | Time Frame |
|---|---|---|
| Determine dosage of REKOVELLE and Menopur in a mixed protocol | Evaluate the effect of adding HP-hMG (Menopur) to follitropin delta (REKOVELLE) during IVF stimulation | up to 20 days |
| Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Bissonnette, MD | Clinique Ovo | Principal Investigator |
| Clifford Librach, MD | CReATe Fertility Centre | Principal Investigator |
| Tom Hannam, MD | Hannam Fertility Centre | Principal Investigator |
| Al Yuzpe, MD | Olive Fertility Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olive Fertility Centre | Vancouver | British Columbia | V5Z 3X7 | Canada | ||
| Hannam Fertility Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33267959 | Derived | Bissonnette F, Minano Masip J, Kadoch IJ, Librach C, Sampalis J, Yuzpe A. Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin. Fertil Steril. 2021 Apr;115(4):991-1000. doi: 10.1016/j.fertnstert.2020.09.158. Epub 2020 Nov 30. |
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| ID | Term |
|---|---|
| C000620228 | follitropin delta |
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The safety profile is the proportion of women with early and late OHSS and/or preventive interventions for early OHSS (i.e., triggering with GnRH agonist, use of dopamine agonist, conversion of planned fresh transfer into a freeze-all). OHSS is defined as an iatrogenic complication that occurs mainly due to ovarian overstimulation by gonadotropins. |
| up to 20 days |
| Toronto |
| Ontario |
| M4W 3R2 |
| Canada |
| CReATe Fertility Centre | Toronto | Ontario | M5G 1N8 | Canada |
| Clinique Ovo | Montreal | Quebec | H4P 2S4 | Canada |