Lutropin Alfa in Women at Risk of Poor Response

• Status: Completed
• Trial end date: 2007-01-30
• Target enrollment: 0
• Participant gender: Female

Summary

Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone [r-hLH]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone [r-FSH]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cetrorelix; Follicle Stimulating Hormone; Progesterone

Criteria

Inclusion Criteria:

• Participants who were at risk of poor response by at least one of the following criteria: a) <3 follicles in last cycle, or less than or equal to (oocytes, or estradiol (E2) <600 pg/mL; b) Cancellation of previous cycle; c) Early follicular serum Follicle-Stimulating Hormone (FSH) >8.5 milli IU/L

• Participants with normal baseline luteinizing hormone and E2 levels

• Regular menstrual cycles of 25-35 days

• Presence of both ovaries and uterus able to withstand pregnancy

Exclusion Criteria:

• Participants who had any clinically significant disease including known human immunodeficiency virus (HIV), hepatitis-B virus (HBV)/hepatitis-C virus (HCV) positivity

• Participants with more than 3 previous assisted reproductive techniques (ART) cycles

• Participants with polycystic ovaries or cyst of unknown etiology; unexplained gynecological bleeding

• Participants who had any contraindication to being pregnant

• Active substance abuse

• Participants who had simultaneously participated in another clinical drug trial