Back to resultsStudy to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)
Primary Purpose
Controlled Ovarian Stimulation, Infertility
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
recombinant luteinizing hormone (r-LH)
recombinant human chorionic gonadotropin (r-hCG)
Sponsored by
About this trial
This is an interventional basic science trial for Controlled Ovarian Stimulation focused on measuring COS, ART, Infertility
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- PCOS
- More than 2 prior IVF/ICSI attempts
- Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.
Sites / Locations
- Fertility Clinic Skive regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
recombinant luteinizing hormone
recombinant human chorionic gonadotrofin
Arm Description
150 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)
25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
Outcomes
Primary Outcome Measures
The Oestradiol Concentration on the Day of Ovulation Induction
Secondary Outcome Measures
Full Information
NCT ID
NCT01339299
First Posted
April 19, 2011
Last Updated
September 25, 2013
Sponsor
Regionshospitalet Viborg, Skive
1. Study Identification
Unique Protocol Identification Number
NCT01339299
Brief Title
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)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regionshospitalet Viborg, Skive
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Controlled Ovarian Stimulation, Infertility
Keywords
COS, ART, Infertility
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
recombinant luteinizing hormone
Arm Type
Experimental
Arm Description
150 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)
Arm Title
recombinant human chorionic gonadotrofin
Arm Type
Active Comparator
Arm Description
25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
Intervention Type
Drug
Intervention Name(s)
recombinant luteinizing hormone (r-LH)
Intervention Description
administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
Intervention Type
Drug
Intervention Name(s)
recombinant human chorionic gonadotropin (r-hCG)
Intervention Description
administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
Primary Outcome Measure Information:
Title
The Oestradiol Concentration on the Day of Ovulation Induction
Time Frame
treatment day 10 to 14
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
PCOS
More than 2 prior IVF/ICSI attempts
Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.
Facility Information:
Facility Name
Fertility Clinic Skive regional Hospital
City
Skive
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
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)
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