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A randomised controlled open-label clinical trial to compare the outcome parameters after ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on day 2 of the cycle versus start in the late follicular phase of the cycle.
Objective: To determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH (Gonadotropin-releasing hormone) antagonist protocol, in oocyte donor patients.
Design: Open label, phase 3 randomized trial using a two-arm design with 1:1 allocation ratio
Patients: Oocyte donors (aged 18-36 years)
Intervention(s): Reference group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
Investigational group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle (evaluation trough ultrasound and hormonal assessment) onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH (Luteinizing Hormone) > 10 IU/L, till day of trigger.
Oocyte maturation trigger with GnRH agonist (0.2mg Gonapeptyl) in both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Late follicular phase stimulation with recombinant-human FSH | Experimental | Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH > 10 IU/L, till day of trigger. |
|
| Early follicular phase stimulation with recombinant-human FSH | Active Comparator | Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Late follicular phase stimulation with recombinant-human FSH | Combination Product | Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH > 10 IU/L, till day of trigger. |
| Measure | Description | Time Frame |
|---|---|---|
| total amount of COC (cumulus-oocyte-complex) | at oocyte aspiration |
| Measure | Description | Time Frame |
|---|---|---|
| Endocrine profile | LH (Luteinising hormone) level | on menstrual cycle day 2 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group |
| Endocrine profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
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Open label, phase 3 pilot randomized trial using a two-arm design with 1:1 allocation ratio
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|
| Early follicular phase stimulation with recombinant-human FSH | Combination Product | Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger. |
|
FSH level |
| on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group |
| Endocrine profile | Progesterone level | on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group |
| Endocrine profile | Estradiol level | on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group |
| Consumption of gonadotrophins | totaal amount of IU (international units) used | during the ovarian stimulation |
| Number of days needed for ovarian stimulation | during the ovarian stimulation |
| Days of GnRH antagonist use | during the ovarian stimulation |
| Total number of mature oocytes | at day of oocyte aspiration |
| Total medication cost | during the ovarian stimulation |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
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