Follistatin 315
Activin-Binding Protein, FSH-Suppressing Protein, FST-315, FS-315
Completed
PHASE2
INTERVENTIONAL
NCT01112358
Lutropin Alfa in Women at Risk of Poor Response
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
r-FSH
Type:
DRUG
Description:
r-FSH will be administered as specified in the arm description.
Name:
r-hLH
Type:
DRUG
Description:
r-hLH will be administered as specified in the arm description.
Name:
Analogous GnRH antagonist
Type:
DRUG
Description:
Analogous GnRH antagonist will be administered as specified in the arm description.
Name:
r-hCG
Type:
DRUG
Description:
r-hCG will be administered as specified in the arm description.
Name:
Progesterone
Type:
DRUG
Description:
Progesterone will be administered as specified in the arm description.
Primary Outcomes
Measure:
Number of Oocytes Retrieved
TimeFrame:
At the end of stimulation (Day 2 up to Day 8)
Description:
Measure:
Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter
TimeFrame:
At the end of stimulation (Day 2 up to Day 8)
Description:
Measure:
Oocytes Recovery Rate
TimeFrame:
At the end of stimulation (Day 2 up to Day 8)
Description:
Oocytes recovery rate (oocytes per \>14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles \>14 mm in diameter.
Trial Information
NCT ID
NCT01112358
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Merck KGaA, Darmstadt, Germany
Last Updated
December 15, 2025