NCT00230815View on ClinicalTrials.gov

A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction

PHASE3CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

November 30, 2005

Study Completion Date

November 30, 2005

Conditions
Infertility
Interventions
DEVICE

Follitropin alfa injected by Pen device

Follitropin alfa will be injected subcutaneously by Pen device at a dose of 75 International Unit (IU) and 150 IU in subjects aged 18-34 and 35-40 years, respectively, for 5 days. Dose will be adjusted on stimulation Day 6 until ovulation triggering criteria will met.

DEVICE

Recombinant Human Choriogonadotropin (r-hCG)

Recombinant Human Choriogonadotropin (r-hCG) injection will be administered as a single dose of 250 microgram subcutaneously when at least 1 follicle, but not more than 3 follicles, reached a mean diameter greater than or equal to (\>=)17 mm and estradiol levels are approximately 150 picogram per milliliter (pg/mL) per mature follicle.

Sponsors

Lead Sponsor

EMD Serono
All Listed Sponsors
lead

EMD Serono

INDUSTRY

NCT00230815 - A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction | Biotech Hunter | Biotech Hunter