To determine which ovarian hyperstimulation regimen (FSH or CC) should be applied in IUI in couples with unexplained subfertility or mild male factor subfertility.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy rate
Secondary outcome
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
Background summary
The first line treatment of patients with unexplained subfertility is intra
uteriene insemination with ovarian hypertstimulation with follicle stimulating
hormone or with clomifene citrate. Ovarian hyperstimulation is done to achieve
multiple dominant follicles, this increases the changes of prengancy. The
downside however is a high the multiple pregancy rate. Therefore the aim is
change to achieving a maximum of two dominant follicles. It is currently
unknown whether this should be done with FSH or Clomifeen citrate. One study
comparing FSH to clomifeen citrate did not show a difference in pregnancy
outcome, however this stude was underpowered and the large majority of Dutch
clinisch continue to stimulate with FSH, resulting in an annual cost of 11
million euro for medication cost alone.
Study objective
To determine which ovarian hyperstimulation regimen (FSH or CC) should be
applied in IUI in couples with unexplained subfertility or mild male factor
subfertility.
Study design
Nationwide parallel multicenter randomised clinical trial, with an economic
analysis alongside it
Intervention
A maximum of 4 cycles of IUI with ovarian stimulation with either FSH or CC in
a time horizon of 6 months.
Study burden and risks
The strategies compared are already applied in current practice. No additional
risks are expected. Patients will be asked to fill in a questionnaire on side
effects. The possible benefit associated with participation is pregnancy in
both groups.
Meibergdreef 9
Amsterdam 1104 AZ
NL
Meibergdreef 9
Amsterdam 1104 AZ
NL
Listed location countries
Age
Inclusion criteria
Couples diagnosed with unexplained subfertility or mild male factor;Unexplained subfertility is defined as:
12 month unprotected regular intercourse
male partner had normal or mild impairment of semen quality with total motile sperm count above 10 millon
female partner has a regular menstrual cycle, at least one sided tubal patency
Poor prognosis for natural conception according to model of Hunault (dutch guidelines) in order to justify start of treatment with IUI
Exclusion criteria
- double sided tubal pathology
- impaired semen quality
- women with irregular cycle
- age below 18 and above 42
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-001034-18-NL |
| CCMO | NL43131.018.13 |