Phase 4
N=100
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)
Controlled Ovarian Stimulation · Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01339299 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: The Oestradiol Concentration on the Day of Ovulation Induction — 11482; 12262 pmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- recombinant luteinizing hormone (r-LH) (Drug); recombinant human chorionic gonadotropin (r-hCG) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Regionshospitalet Viborg, Skive
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Oestradiol Concentration on the Day of Ovulation Induction |
11482; 12262 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01339299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.