Prevention of multiple pregnancies in couples with unexplained or mild male subfertility.
- Conditions
- unexplained subfertility and mild male subfertility1002892010013356
- Registration Number
- NL-OMON30790
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 600
1. Female age between 18 and 38 years.
2. Failure to conceive within at least 12 months of unprotected intercourse .
3. The couple has poor fertility prospects as calculated by the validated model of Hunault (Hunault et al., 2005, Van der Steeg et al., 2007). A poor fertility prospect is defined as a chance of spontaneous pregnancy below 30% within 12 months.
1. Anovulation
2. Post-wash total motile sperm count below 3 million.
3. Double-sided tubal pathology
4. Endocrinopathological disease like: Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, imminent ovarian failure, premature ovarian failure, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I.
5. Negative post-coitus test
6. 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 <p>Primary outcome is the birth of a healthy child. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are singleton and multiple ongoing pregnancy rates, clinical<br /><br>pregnancy rate, neonatal and maternal complications, patient preference and<br /><br>costs. </p><br>