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.
- Conditions
- nexplained subfertility or mild male subfertility
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ongoing pregnancy defined as registered heartbeat on ultrasound beyond 12 weeks of gestation.
- Secondary Outcome Measures
Name Time Method 1. Multiple pregnancy, defined as registered heartbeat of at least two foetuses at 12 weeks of gestation; <br>2. Clinical pregnancy, defined as any registered embryonic heartbeat at sonography; <br>3. Live birth, defined as the birth of at least one living child;<br>4. Pregnancy complications (preterm birth < 37 weeks, birth weight < 2.500 gram, Pregnancy Induced Hypertension (PIH), (pre-) eclampsia, HELLP).