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NCT01339299 Clinical 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)

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01339299
Other study ID # 700642-603
Secondary ID 2009-009375-35
Status Completed
Phase Phase 4
First received April 19, 2011
Last updated September 25, 2013
Start date October 2009
Est. completion date July 2012

Study information
Verified date April 2011
Source Regionshospitalet Viborg, Skive
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• recombinant luteinizing hormone (r-LH)
administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
• recombinant human chorionic gonadotropin (r-hCG)
administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)

Locations
Country Name City State
Denmark Fertility Clinic Skive regional Hospital Skive

Sponsors (1)
Lead Sponsor Collaborator
Regionshospitalet Viborg, Skive

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Oestradiol Concentration on the Day of Ovulation Induction treatment day 10 to 14 No
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