Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)

PHASE2CompletedINTERVENTIONAL
Enrollment

520

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Infertility
Interventions
DRUG

AS900672-Enriched 50 microgram (mcg)

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.

DRUG

AS900672-Enriched 100 mcg

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.

DRUG

AS900672-Enriched 150 mcg

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.

DRUG

Follitropin alfa 150 international unit (IU)

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.

DRUG

Recombinant human chorionic gonadotropin (r-hCG)

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).

Trial Locations (1)

02370

Local US Medical Information Office, Rockland

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT00505752 - Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART) | Biotech Hunter | Biotech Hunter