Efficacy and Safety of R-hLH (Luveris ®) Priming Prior to R-HFSH Treatment in Infertile Women Undergoing IVF-ET
1 other identifier
interventional
160
3 countries
3
Brief Summary
In programmes of IVF, normal women undergo controlled ovarian stimulation using exogenous FSH injections to obtain multiple eggs. The process results in eggs of mixed quality with a broad range of developmental and implantation potential. The aim of the study was to determine whether, treatment with recombinant human LH prior to the FSH injections can improve outcome for women undergoing IVF. High grade embryos implant with a higher frequency and baby delivery rate than poor quality embryos. The mature oocyte is the most important determinant of embryo quality. Early follicles, containing immature eggs, have LH receptors in the theca cells that surround the follicle, and LH stimulates these cells to produce factors essential for normal follicular development. The intent of the study was to use recLH treatment prior to recFSH to treat a cohort of follicles, so that they can all mature together, thus increasing the proportion of high grade oocytes and their subsequent embryos
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2003
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
February 28, 2007
CompletedFebruary 28, 2007
February 1, 2007
February 27, 2007
February 27, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Numbers of oocytes
Numbers of embryos
Numbers if high grade embryos
Secondary Outcomes (2)
Duration of FSH injections
Numbers of FSH injections
Interventions
Eligibility Criteria
You may qualify if:
- infertile undergoing IVF
- normal menstrual rhythm
You may not qualify if:
- polycystic ovaries
- known resistance to FSH
- other drug preparations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Fertility Clinic, Department of Obstetrics and Gynaecology, University Hospital of Odense, 5000
Odense, Denmark
Reproductive Medicine Unit, Department of Gynaecology and Obstetrics, Jean Verdier Hospital, University Paris XIII
Paris, France
Assisted Conception Unit., Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Related Publications (1)
Durnerin CI, Erb K, Fleming R, Hillier H, Hillier SG, Howles CM, Hugues JN, Lass A, Lyall H, Rasmussen P, Thong J, Traynor I, Westergaard L, Yates R; Luveris Pretreatment Group. Effects of recombinant LH treatment on folliculogenesis and responsiveness to FSH stimulation. Hum Reprod. 2008 Feb;23(2):421-6. doi: 10.1093/humrep/dem388. Epub 2007 Dec 15.
PMID: 18084048DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Fleming, PhD
NHS Greater Glasgow and Clyde
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 27, 2007
First Posted
February 28, 2007
Study Start
March 1, 2003
Study Completion
February 1, 2006
Last Updated
February 28, 2007
Record last verified: 2007-02