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Superovulation in intra uterine insemination: FSH or clomifene citrate?

Superovulation in intra uterine insemination: FSH or clomifene citrate?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25229
Enrollment
732
Registered
2013-07-01
Start date
2013-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unexplained infertility, intra uterine insemination, FSH, clomifene citrate

Interventions

4 cycles IUI-FSH or 4 cycles IUI-clomifene citrate

Sponsors

Academic Medical Center
Lead Sponsor

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

MeasureTime frame
Cumulative ongoing pregnancy rate

Secondary

MeasureTime 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

Public ContactM.H. Mochtar

Academical Medical Center, Center for Reproductive Medicine

M.H.Mochtar@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)