Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GONAL-f · 2 trials · 5 indications
The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.
Number of subjects who self-administered the IMP were presented in this outcome measure.
| Arm | Type | Description |
|---|---|---|
| Gonal-f® Plus Pergoveris® | ACTIVE_COMPARATOR | - |
| Pergoveris® | EXPERIMENTAL | - |
| GONAL-f® | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Gonal-f® | DRUG | Gonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5). |
| Pergoveris® | DRUG | Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 1 follicles \>= 18 mm). The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice. |
| Recombinant human chorionic gonadotropin (r-hCG) | DRUG | 250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles \>= 18 mm). |
Inclusion Criteria: * Be a female subject justifying an in vitro fertilization and embryo transfer (IVF/ET) treatment * Be between her 36th and 40th birthday (both included) at the time of the randomization visit * Have early follicular phase (Day 2-4) serum level of basal follicle stimulating horm...
GONAL-f is used in assisted reproductive techniques and for infertility treatment, including ovulation induction and in-vitro fertilization. It is being studied in clinical trials for these indications in women aged 18 years and older.
GONAL-f is developed by Merck KGaA, a biopharmaceutical company. The company's stock is traded under the ticker MKGAF.
GONAL-f is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy.
GONAL-f has been studied in clinical trials including NCT01183143, which evaluated a liquid formulation applied by pen for ovulation induction and in-vitro fertilization, and NCT01297465, which assessed its use in stratified treatment for assisted reproductive techniques. Both trials were completed.
GONAL-f is not the same as Pergoveris. GONAL-f is a separate drug developed by Merck KGaA. The clinical trial NCT01297465, titled 'PERgoveriS In Stratified Treatment for Assisted Reproductive Technique,' studied GONAL-f in combination with other treatments, but GONAL-f itself is a distinct product.