The efficacy of GnRH antagonists in cycles with mild ovarian hyperstimulation with recFSH in an intrauterine insemination program.A randomised placebo-controlled double-blinded investigator initiated study.
- Conditions
- Eligible for consideration are couples who are primarily undesirably non-pregnant and for whom an IUI procedure is suggested as a viable treatment option. A routine fertility check-up as defined, for instance, in the guidelines of the Dutch Society of Obstetrics and Gynaecology will be performed in this study. This defines the concepts of subfertility, previous history, physical examination (in this study including recording of the height and weight), laboratory tests and fertility work-up.
- Registration Number
- NL-OMON22749
- Lead Sponsor
- noneSerono Benelux B.V. will provide all centres with the necessary drugs
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 520
Inclusion Criteria
Primary and secondary subfertile patients between 18 and 35 years of age with a diagnosis of unexplained or mild male infertility (see above) will be included.
Definition of unexplained subfertility:
Exclusion Criteria
1. Age of the woman < 18 or > 35 years;
2. Duration of subfertility below 2 years;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method