Implantation failure as a cause of unexplained infertility; determinants of the successrate in ART in women with unexplained infertility.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

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 < 10, no anticardiolipin antibodies/ lupus anticoagulant/ Factor V Leiden mutation/ prothrombin gene mutation/ deficiencies in protein S/ protein C and antithrombin, no abnormal TSH. ;Reference group normal implanters (only data will be used)
• Women who have conceived after ICSI treatment for male factor infertility.
• Women who were included in study 05/225-K.;Reference group normal fertile women
• Women who have never showed any fertility disorders (preferably already conceived and delivered).

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are:<br /><br>• ßHCG levels in urine<br /><br>• Cytokine expression in endometrial secretion/ culture<br /><br><br /><br>The main study endpoint is:<br /><br>• Cumulative pregnancy rate<br /><br>• Early pregnancy loss rate<br /><br>• The embryo secretion cytokine expression profile<br /><br>• The endometrial secretion cytokine expression profile before embryo transfer.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are:<br /><br>• Lifestyle factors: physical exercise, smoking, use of caffeine and alcohol,<br /><br>BMI (body mass index)<br /><br>• uNK cell count, endometritis<br /><br>• PI van de a uterina before ET<br /><br><br /><br>The secondary study endpoints are:<br /><br>• Correlation between secondary study parameters and diagnosis of unexplained<br /><br>infertility<br /><br>• Early pregnancy loss rate</p><br>