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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)

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ClinicalTrials.gov Identifier: NCT01016210
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : January 17, 2014
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by:
The Baruch Padeh Medical Center, Poriya

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Result Rape Drug: Leuveris Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2013

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: Starting February 2010 ]

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


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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

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

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

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