unexplained infertility, intra uterine insemination, FSH, clomifene citrate
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -At least 12 months of unprotected intercourse without conception. -At least one sided tubal patency, which is established according to local protocol. -The male partner or semen-donor has normal semen quality or mild impairment of semen quality. Mild male subfertility is defined as abnormal semen parameters according to the WHO but an average total motile sperm account before processing of at least 10 million based on the average of two semen analyses. -The 12-month prognosis for the couple to conceive naturally has to be below 30% according to the model of Hunault.
Exclusion criteria
Exclusion criteria: -Double sided tubal pathology -Women with irregular cycles, PCOS or other endocrine disorders -Impaired semen quality: pre-wash TMC<10 million -Women younger than 18 or older than 43 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative ongoing pregnancy rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of cycles with monofollicular growth 2. Number of cycles with multiple follicle growth 3. Number of cancelled cycles due to the occurrence of >3 follicles >15 mm 4. Difference in severity of known adverse effects 5. Time to ongoing pregnancy rate 6. Clinical pregnancy 7. Miscarriage rate 8. Live birth rate 9. Multiple pregnancies 10. Patients preference by DCE 11. Direct and indirect costs | — |
Contacts
Academical Medical Center, Center for Reproductive Medicine