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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:
ClinicalTrials.gov Identifier:
NCT01016210
First Posted: November 19, 2009
Last Update Posted: January 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Israel
Information provided by:
The Baruch Padeh Medical Center, Poriya
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Fertilization rate [ Time Frame: Starting February 2010 till April 2013 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016210


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

Responsible Party: DR Joni Younis, The baruch Padeh Medical center
ClinicalTrials.gov Identifier: NCT01016210     History of Changes
Other Study ID Numbers: Leuveris1.CTIL
First Submitted: November 18, 2009
First Posted: November 19, 2009
Last Update Posted: January 17, 2014
Last Verified: January 2014

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