idiopathic subfertility unexplained infertility
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Study group • Women with unexplained infertility after routine fertility and PEPSI screening. • Women who will start their first IVF treatment cycle. ;Definition unexplained infertility: • There must be a regular cycle (between 21-42 days), • normal semen analysis (VCM > 10 million, normal morpholohy > 14%), • no tubal factor (no abnormalities on hysterosalpingografy and negative CAT) and • no abnormlaities on the hysteroscopy (partial septum, submucosal/Intramural fibroids, endometrial polyps, adhesions, chronic and acute endometritis: diagnosed by the pathologist) • no abnormalities from blood screening: FSH
Exclusion criteria
Exclusion criteria: Study group • PESA (percutaneous epididymal sperm aspiration) / MESA (microsurgical epididymal sperm aspiration / TESE (testicular sperm extraction) • Difficulty in communicating in Dutch or English • Women older than 37 years;Reference group of normal fertile women • Women older than 37 years • Women who have already tried to conceive for more than four months/ who have had any fertility disorders in the past.;Exclusion criteria for endometrial secretion aspiration: • Excisional procedures to treat cervical intraepithelial neoplasia and no previous uncomplicated ET/IUI. • Previous ducumented difficult intra uterine inseminations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are: • ßHCG levels in urine • Cytokine expression in endometrial secretion/ culture The main study endpoint is: • Cumulative pregnancy rate • Early pregnancy loss rate • The embryo secretion cytokine expression profile • The endometrial secretion cytokine expression profile before embryo transfer. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are: • Lifestyle factors: physical exercise, smoking, use of caffeine and alcohol, BMI (body mass index) • uNK cell count, endometritis • PI van de a uterina before ET The secondary study endpoints are: • Correlation between secondary study parameters and diagnosis of unexplained infertility • Early pregnancy loss rate | — |
Countries
Netherlands