A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women

PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

December 31, 1999

Primary Completion Date

July 31, 2001

Study Completion Date

July 31, 2001

Conditions
Infertility
Interventions
DRUG

r-hFSH

Daily r-hFSH treatment will be administered subcutaneously at a starting dose according to the site's standard practice from Day 3-5 of menstrual cycle up to follicular development or 28 days. Dose can be altered according to ovarian response (reduced to 75 IU/day; increased to 225 IU/day).

DRUG

r-hLH

Ovulation triggering will be performed using a single injection of r-hLH injection subcutaneously at a dose of 825 or 2750 or 5500 or 11,000 or 22,000 IU as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter \>= 18 mm, not more than 5 follicles with diameter \>= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L).

DRUG

u-hCG

Ovulation triggering will be performed using a single injection of 5000 IU of u-hCG as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter \>= 18 mm, not more than 5 follicles with diameter \>= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L).

Trial Locations (1)

Unknown

Royal University Hospital, Saskatoon

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01735422 - A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women | Biotech Hunter | Biotech Hunter