Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AS900672-Enriched 50 microgram (mcg)
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 studied for infertility. It was evaluated in infertile women undergoing assisted reproductive technology (ART). The drug is a long-acting follicle stimulating hormone formulation developed by Merck KGaA. It is not approved and remains in clinical development.
AS900672-Enriched 50 microgram is developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the Phase 2 trial of the drug in infertile women undergoing assisted reproductive technology. Merck KGaA is the sole developer named for this asset.
AS900672-Enriched 50 microgram is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication. It was studied in infertile women undergoing assisted reproductive technology.
AS900672-Enriched 50 microgram was studied in one 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 participants, was randomized and active-controlled, and has completed. It was conducted in the United States in women aged 18 years and older.