A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve

PHASE2CompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

January 10, 2005

Primary Completion Date

November 15, 2006

Study Completion Date

November 15, 2006

Conditions
InfertilityOvulation Induction
Interventions
DRUG

Recombinant human follicle stimulating hormone (r-hFSH)

Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day \[mg/day\]).

DRUG

Recombinant human luteinizing hormone (r-hLH)

Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation.

Trial Locations (1)

Unknown

Hospital de Cruces, Plaza de Cruces, 12, 48903, Vizcaya

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01110707 - A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve | Biotech Hunter | Biotech Hunter