A prospective randomized multicentre study to compare Crinone 8% once daily versus other vaginal progesterone.
Phase 1
- Conditions
- uteal support in connnection with IVF treatment.
- Registration Number
- EUCTR2005-001248-22-DK
- Lead Sponsor
- Fertilitetsklinikken Nordica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 2686
Inclusion Criteria
Women <40 years who are under going IVF treatment and are willing to sign Informed Consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Women who are not willing to sign Informed Consent form.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to show equivalence in ongoing pregnancy per embryo transfer (ET) between the two groups;Secondary Objective: To show that Crinone 8% is superior to other vaginal progesterone in terms of convenience. Other secondary objectives are to compare positive hCG, implantation rate, bleeding pattern before pregnancy test, live birth rate and multiple live birth rate.;Primary end point(s): On-going pregancy per ET minimum 5 weeks after ET
- Secondary Outcome Measures
Name Time Method