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NCT01016210 Clinical Trial

The Effect of Luteinizing Hormone (LH) Supplementation Following Gonadotropin-releasing Hormone (GnRH) Antagonist Administration in Advanced Reproductive Ageing Women Undergoing IVF and Embryo Transfer (IVF/ET)

Pregnancy Result Rape Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01016210
Other study ID # Leuveris1.CTIL
Secondary ID
Status Completed
Phase Phase 4
First received November 18, 2009
Last updated January 16, 2014
Start date February 2010
Est. completion date April 2013

Study information
Verified date January 2014
Source The Baruch Padeh Medical Center, Poriya
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

To explore whether recombinant LH (rLH) supplementation (Leuveris) to recombinant follicle stimulating hormone (rFSH) following GnRH antagonist treatment has an advantage in infertile women with advanced reproductive ageing undergoing IVF-ET.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 2013
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria:

- female candidate to IVF

- between 30-45 years old

Exclusion Criteria:

- not included for fertilization

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Leuveris
IV
• Leuveris
All recruited women will be treated similarly employing the recombinant FSH and the fixed GnRH antagonist. Concomitantly, on the same day of the antagonist administration r-LH will be administered daily and continued until human chorionic gonadotropin (hCG) day.

Locations
Country Name City State
Israel Poriya hospital Tiberias

Sponsors (2)
Lead Sponsor Collaborator
The Baruch Padeh Medical Center, Poriya Ministry of Health, Israel

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy rate Starting February 2010 No
Secondary Fertilization rate Starting February 2010 till April 2013 No