Unexplained subfertility or mild male subfertility
Conditions
Interventions
Comparison of IVF in a long protocol with elective Single Embryo Transfer, and IUI-COH, in couples with unexplained or mild male subfertility and poor fertility prospects.
Sponsors
None listed
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy defined as registered heartbeat on ultrasound beyond 12 weeks of gestation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Multiple pregnancy, defined as registered heartbeat of at least two foetuses at 12 weeks of gestation; 2. Clinical pregnancy, defined as any registered embryonic heartbeat at sonography; 3. Live birth, defined as the birth of at least one living child; 4. Pregnancy complications (preterm birth < 37 weeks, birth weight < 2.500 gram, Pregnancy Induced Hypertension (PIH), (pre-) eclampsia, HELLP). | — |
Contacts
Public ContactI. Custers
Academic Medical Center (AMC), Department of Obstetrics and Gynecology, Center for Reproductive Medicine P.O. Box 22660
Outcome results
None listed