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)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
The Baruch Padeh Medical Center, Poriya
Information provided by:
The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT01016210
First received: November 18, 2009
Last updated: December 22, 2010
Last verified: December 2010
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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 |
Resource links provided by NLM:
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 |
| Estimated Study Completion Date: | April 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016210
Contacts
| Contact: Jonni Jounis, MD | 97246652490 | jyounis@poria.health.gov.il |
Locations
| Israel | |
| Poriya hospital | Recruiting |
| Tiberias, Israel, 15208 | |
| Contact: Orit radon, MSc | |
| Contact: aviva peleg, Msc 97246652236 apeleg@poria.health.gov.il | |
Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
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: | December 22, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by The Baruch Padeh Medical Center, Poriya:
|
pregnancy IVF |
ClinicalTrials.gov processed this record on May 16, 2013