NL-OMON21644
Recruiting
Not Applicable
Treatment of couples with unexplained subfertility and an unfavourable prognosis. A randomised trial comparing the effectiveness of IUI with ovarian hyperstimulation and IVF with single embryo transfer.
Not provided0 sites100 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- nexplained subfertility or mild male subfertility
- Sponsor
- Not provided
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female age between 18 and 36 years;
- •2\. Couples must be diagnosed with unexplained subfertility, defined as normal semen (pre\-wash total motile sperm count of at least 40 million), spontaneous ovulatory cycle and patent Fallopian tubes, or with mild male subfertility, defined as a post\-wash total motile sperm count above 3 million;
- •3\. The couple has poor fertility prospects as calculated by the validated model of Hunault (Hunault et al., 2005, Van der Steeg et al., Submitted). A poor fertility prospect is defined as a chance of spontaneous pregnancy below 30% within 12 months.
Exclusion Criteria
- •1\. Polycystic ovary syndrome;
- •2\. Endocrinopathological disease like: Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, imminent ovarian failure, premature ovarian failure, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I;
- •3\. If not willing or able to sign the consent form.
Outcomes
Primary Outcomes
Not specified
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