Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)

Phase 4

Completed

• Conditions: Controlled Ovarian Stimulation; Infertility
• Interventions: Drug: recombinant luteinizing hormone (r-LH); Drug: recombinant human chorionic gonadotropin (r-hCG)

• Registration Number: NCT01339299
• Lead Sponsor: Regionshospitalet Viborg, Skive

Brief Summary

The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Status Verified: 2011-04
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2013-09-25
• Results First Submitted QC: 2013-09-25
• Last Update Submitted: 2013-09-25
• Results First Posted: 2013-11-27
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women who plan to undergo IVF or ICSI treatment
• Woman's age > 18 years but ≤ 35 years
• Regular menstrual cycle (25-34 days)
• BMI 18 to 30 inclusive
• Signed patient information and informed consent forms

Exclusion Criteria

• PCOS
• More than 2 prior IVF/ICSI attempts
• Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
recombinant luteinizing hormone	recombinant luteinizing hormone (r-LH)	150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)
recombinant human chorionic gonadotrofin	recombinant human chorionic gonadotropin (r-hCG)	25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )

Primary Outcome Measures

Name	Time	Method
The Oestradiol Concentration on the Day of Ovulation Induction	treatment day 10 to 14

Trial Locations

Locations (1)

Fertility Clinic Skive regional Hospital; 🇩🇰 Skive, Denmark