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Lutropin Alfa in Women at Risk of Poor Response

NCT01112358 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2018-08-28

Study results available
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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.

Conditions

  • Ovarian Stimulation

Interventions

DRUG

r-FSH

r-FSH will be administered as specified in the arm description.

DRUG

r-hLH

r-hLH will be administered as specified in the arm description.

DRUG

Analogous GnRH antagonist

Analogous GnRH antagonist will be administered as specified in the arm description.

DRUG

r-hCG

r-hCG will be administered as specified in the arm description.

DRUG

Progesterone

Progesterone will be administered as specified in the arm description.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-07
Primary Completion
2007-01-30
Completion
2007-01-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01112358 on ClinicalTrials.gov