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)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by:
The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT01016210
First received: November 18, 2009
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Pregnancy Result Rape
Drug: Leuveris
Phase 4

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

Further study details as provided by The Baruch Padeh Medical Center, Poriya:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: Starting February 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fertilization rate [ Time Frame: Starting February 2010 till April 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2010
Study Completion Date: April 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 60 infertile women
Candidates for IVF-ET treatment
Drug: Leuveris
IV
Drug: 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.
No Intervention: control
no treatment

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female candidate to IVF
  • between 30-45 years old

Exclusion Criteria:

  • not included for fertilization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016210

Locations
Israel
Poriya hospital
Tiberias, Israel, 15208
Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Ministry of Health, Israel
  More Information

No publications provided

Responsible Party: DR Joni Younis, The baruch Padeh Medical center
ClinicalTrials.gov Identifier: NCT01016210     History of Changes
Other Study ID Numbers: Leuveris1.CTIL
Study First Received: November 18, 2009
Last Updated: January 16, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by The Baruch Padeh Medical Center, Poriya:
pregnancy
IVF

ClinicalTrials.gov processed this record on September 18, 2014