Intrauterine insemination for unexplained or mild male subfertility
Completed
- Conditions
- nexplained subfertility, onverklaarde subfertiliteit, intrauterine insemination, intra uteriene inseminatie, IUI, expectant management, expectatief
- Registration Number
- NL-OMON29303
- Lead Sponsor
- AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1091
Inclusion Criteria
12 months unprotected intercourse without conception, female age between 18 and 42 years, a regular ovulatory cycle and at least one patent fallopian tube. The male partner has no or a mild impairment of semen quality with a total motile sperm count (TMSC or VCM) above 3 million. Obtained written informed consent. A 12-month prognosis for natural conception (calculated according to the model of Hunault) of 30% or less, or a 12-month prognosis of more than 30% and returning after 6 months of expectant management without conception.
Exclusion Criteria
IUI-OH with sperm donation, couples with a medical contra indication for pregnancy, couples with previous ART in the current treatment episode
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is ongoing pregnancy leading to a live birth occurring within 6 months after randomization. Live birth is defined as the birth of a live baby at 24 or more weeks of gestation.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are number of incomplete/cancelled cycles, clinical pregnancy (defined as the presence of a gestational sac at 5-7 weeks after IUI) ongoing pregnancy, (defined as a the presence of a positive heartbeat at 10 weeks after IUI), multiple pregnancy (defined as two or more gestational sacs at 5-7 weeks after IUI), ongoing multiple pregnancy (defined as the presence of two or more heart beats at 10 weeks after IUI), miscarriage (defined as the loss of a pregnancy prior to 16 weeks gestation), ectopic pregnancy ( defined as the ectopic nidation of a pregnancy), time to ongoing pregnancy, pregnancy outcomes (such as birth weight and premature birth or pre-eclampsia), couples preference, quality of life and financial costs.