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AS900672-Enriched 50 microgram · 1 trial · 1 indication
Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.
| Arm | Type | Description |
|---|---|---|
| AS900672-Enriched 50 mcg | EXPERIMENTAL | - |
| AS900672-Enriched 100 mcg | EXPERIMENTAL | - |
| AS900672-Enriched 150 mcg | EXPERIMENTAL | - |
| Follitropin alfa 150 IU | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AS900672-Enriched 50 microgram (mcg) | DRUG | Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days. |
| AS900672-Enriched 100 mcg | DRUG | Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days. |
| AS900672-Enriched 150 mcg | DRUG | Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days. |
| Follitropin alfa 150 international unit (IU) | DRUG | Follitropin alfa (Gonal-f®) 150 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 50, 100 and 150 mcg will also receive daily dose of follitropin alfa 150 IU subcutaneously from Stimulation Day 6 (S6) up to S21. Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days. |
| Recombinant human chorionic gonadotropin (r-hCG) | DRUG | Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, at least 1 follicle with a diameter of greater than or equal to \[\>=\] 18 millimeter \[mm\], two or more additional follicles with a diameter of \>= 16 mm, and Estradiol \[E2\] levels will approximately 150 picogram per milliliter \[pg/mL\] per mature follicle). |
Inclusion Criteria : * Infertility and desire to conceive, justifying ART treatment * Age between 18 and 36 years, inclusive, at time of informed consent * Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m\^2), inclusive * Regular spontaneous menstrual cycles of 21 to 35 days * Presenc...
AS900672-Enriched 50 microgram is an investigational small molecule being developed for infertility. It is being studied in infertile women undergoing assisted reproductive technology (ART). The drug is currently in Phase 2 clinical development and is not approved by regulatory authorities.
AS900672-Enriched 50 microgram is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is an investigational small molecule intended for the treatment of infertility and is currently in Phase 2 clinical trials.
AS900672-Enriched 50 microgram is in Phase 2 clinical development. It is an investigational drug for infertility and has not been approved by regulatory authorities. One Phase 2 trial has been completed, involving 520 participants.
AS900672-Enriched 50 microgram has one completed Phase 2 trial, NCT00505752, titled 'Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)'. The trial enrolled 520 women in the United States and was active-controlled.
AS900672-Enriched 50 microgram is being investigated as a long-acting follicle stimulating hormone in a clinical trial for infertility. The Phase 2 study NCT00505752 evaluated this drug in infertile women undergoing assisted reproductive technology.