Number of Oocytes Retrieved
| Group | Value (Oocytes) | Spread |
|---|---|---|
| Gonal-f 75 IU | 8.3 | 4.5 |
| Gonal-f 112.5 IU | 9.6 | 6.5 |
| Gonal-f 150 IU | 12.1 | 6.4 |
| Gonal-f 187.5 IU | 12.7 | 4.3 |
| Gonal-f 225 IU | 8.3 | 3.8 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataShort name CONSORT
France
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.
Experimental
Gonal-f 112.5 IU
Experimental
Gonal-f 37.5 IU
Experimental
Gonal-f 75 IU
Experimental
Gonal-f 150 IU
Experimental
Gonal-f 187.5 IU
Experimental
Gonal-f 225 IU
Experimental
Gonal-f 262.5 IU
Experimental
Gonal-f 300 IU
Outcomes the sponsor listed as primary.
Number of Oocytes Retrieved
Time frame · Ovum pick up day (34 to 38 hours post r-hCG administration)
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
Time frame · up to end of stimulation cycle (approximately 31 days)
As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Mean Number of Ovarian Stimulation Days
Time frame · up to end of stimulation cycle (approximately 31 days)
The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH
Time frame · up to end of stimulation cycle (approximately 31 days)
As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Number of Subjects Needing Dose Adjustment
Time frame · 6 days post r-hFSH treatment
Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose
Time frame · up to end of stimulation cycle (approximately 31 days)
As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Embryo Implantation Rate
Time frame · 35-42 days post r-hCG administration
Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate
Time frame · 35-42 days post r-hCG administration
Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Oocytes) | Spread |
|---|---|---|
| Gonal-f 75 IU | 8.3 | 4.5 |
| Gonal-f 112.5 IU | 9.6 | 6.5 |
| Gonal-f 150 IU | 12.1 | 6.4 |
| Gonal-f 187.5 IU | 12.7 | 4.3 |
| Gonal-f 225 IU | 8.3 | 3.8 |
| Group | Value (International Units (IU)) | Spread |
|---|---|---|
| Gonal-f 75 IU | 1102.3 | 671.8 |
| Gonal-f 112.5 IU | 1287.2 | 447.0 |
| Gonal-f 150 IU | 1632.4 | 341.5 |
| Gonal-f 187.5 IU | 2043.8 | 276.2 |
| Gonal-f 225 IU | 2572.5 | 552.3 |
| Group | Value (Days) | Spread |
|---|---|---|
| Gonal-f 75 IU | 12.5 | 4.4 |
| Gonal-f 112.5 IU | 11.0 | 2.9 |
| Gonal-f 150 IU | 10.6 | 1.8 |
| Gonal-f 187.5 IU | 11.0 | 1.4 |
| Gonal-f 225 IU | 11.5 | 2.4 |
| Group | Value (Percentage of cycles) |
|---|---|
| Gonal-f 75 IU | 0.0 |
| Gonal-f 112.5 IU | 0.0 |
| Gonal-f 150 IU | 2.9 |
| Gonal-f 187.5 IU | 0.0 |
| Gonal-f 225 IU | 0.0 |
| Group | Value (subjects) |
|---|---|
| Gonal-f 75 IU | 7 |
| Gonal-f 112.5 IU | 3 |
| Gonal-f 150 IU | 3 |
| Gonal-f 187.5 IU | 1 |
| Gonal-f 225 IU | 0 |
| Group | Value (IU/day) | Spread |
|---|---|---|
| Gonal-f 75 IU | 84.4 | 21.6 |
| Gonal-f 112.5 IU | 114.7 | 16.4 |
| Gonal-f 150 IU | 153.6 | 12.8 |
| Gonal-f 187.5 IU | 186.5 | 5.8 |
| Gonal-f 225 IU | 223.3 | 5.3 |
| Group | Value (Percent sacs per embryo) | Spread |
|---|---|---|
| Gonal-f 75 IU | 36.5 | 42.8 |
| Gonal-f 112.5 IU | 24.3 | 35.0 |
| Gonal-f 150 IU | 28.2 | 38.9 |
| Gonal-f 187.5 IU | 37.1 | 40.5 |
| Gonal-f 225 IU | 11.9 | 20.9 |
| Group | Value (Percentage of subjects) |
|---|---|
| Gonal-f 75 IU | 17 |
| Gonal-f 112.5 IU | 18 |
| Gonal-f 150 IU | 16 |
| Gonal-f 187.5 IU | 16 |
| Gonal-f 225 IU | 2 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Gonal-f 75 IUGONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle \>=18 mm and 2 follicles \>=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. | – | 3 / 48 | 11 / 48 |
| Gonal-f 112.5 IUGONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle \>=18 mm and 2 follicles \>=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. | – | 3 / 45 | 15 / 45 |
| Gonal-f 150 IUGONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle \>=18 mm and 2 follicles \>=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. | – | 1 / 34 | 5 / 34 |
| Gonal-f 187.5 IUGONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle \>=18 mm and 2 follicles \>=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. | – | 1 / 24 | 10 / 24 |
| Gonal-f 225 IUGONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle \>=18 mm and 2 follicles \>=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. | – | 0 / 10 | 3 / 10 |
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