Insemination, Artificial
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of fallopian sperm perfusion (FSP) in comparison with standard intrauterine insemination (IUI) in natural cycle for couples with unexplained infertility or mild male factor.
Detailed description
A number of randomised controlled trials have been published comparing the efficacy of FSP with standard IUI. A recent meta-analysis has suggested that in couples with unexplained infertility Fallopian tube sperm perfusion together with controlled ovarian hyperstimulation (COH) leads to increased pregnancy rates than IUI and COH. No study has been published comparing the two insemination techniques in natural cycle.
Interventions
PROCEDUREFallopian tube sperm perfusion
Patients are treated with fallopian tube sperm perfusion
PROCEDUREIntrauterine insemination using standard catheter
Patients are treated with standard intrauterine insemination
Sponsors
IRCCS Burlo Garofolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* infertility for at least 2 years * age \<40 years * unexplained infertility or mild male factor
Exclusion criteria
* previous assisted reproduction treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical pregnancy rate | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Abortion rate | 2 years |
| Ectopic pregnancy rate | 2 years |
Countries
Italy
Outcome results
None listed