Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)
The Endocrine Efficacy of Either Recombinant Luteinizing Hormone (r-LH) or Low Dose Recombinant Human Chorionic Gonadotropin (r-hCG) Supplementation for Recombinant Follicle Stimulating Hormone (r-FSH) Stimulation in Normogonadotrophic Women Undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Therapy Following a Long-term Gonadotropin Releasing Hormone (GnRH) Agonist Down Regulation Protocol
2 other identifiers
interventional
100
1 country
1
Brief Summary
The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women.
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 Oct 2009
Typical duration for phase_4
1 active site
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
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 19, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
November 27, 2013
CompletedNovember 27, 2013
April 1, 2011
2.8 years
April 19, 2011
September 25, 2013
September 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Oestradiol Concentration on the Day of Ovulation Induction
treatment day 10 to 14
Study Arms (2)
recombinant luteinizing hormone
EXPERIMENTAL150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)
recombinant human chorionic gonadotrofin
ACTIVE COMPARATOR25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
Interventions
administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
Eligibility Criteria
You may qualify if:
- Women who plan to undergo IVF or ICSI treatment
- Woman's age \> 18 years but ≤ 35 years
- Regular menstrual cycle (25-34 days)
- BMI 18 to 30 inclusive
- Signed patient information and informed consent forms
You may not qualify if:
- PCOS
- More than 2 prior IVF/ICSI attempts
- Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fertility Clinic Skive regional Hospital
Skive, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof, M.D. Peter Humaidan
- Organization
- Fertility Clinic Regional Hospital Skive
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. M.D. D.M.Sc.
Study Record Dates
First Submitted
April 19, 2011
First Posted
April 20, 2011
Study Start
October 1, 2009
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 27, 2013
Results First Posted
November 27, 2013
Record last verified: 2011-04