Maternal and embryonic determinants of recurrent embryo implantation failure after assisted reproductive techniques.

Completed

• Conditions: recurrent implantation failure; sterility; 10038612

• Registration Number: NL-OMON30147
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Study group
• Women who have not achieved a pregnancy, despite the consecutive transfer of at least 4 normal/ high quality embryos.
o Cryo-thawed embryos, which are of normal/ high quality after thawing are also included.
o An abortion/ E.U.G. will be regarded as a pregnancy.;Reference group
• Women who conceived after the first or second embryo transfer during ICSI treatment for male factor infertility and who have delivered a healthy baby.

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;Exclusion criteria for endometrial secretion aspiration:
• Excisional procedures to treat cervical intraepithelial neoplasia and no previous uncomplicated ET.
• Previous documented difficult embryo transfer ;Reference group
• Use of oral anticonceptives/ IUD
• Breastfeeding

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are:<br /><br>• Uterine Natural Killer cell count in follicular phase endometrial biopsy<br /><br>(PEPSI)<br /><br>• Uterine Natural Killer cell count in luteal phase endometrial biopsy<br /><br>• The embryo secretion cytokine expression profile<br /><br>• The endometrial secretion cytokine expression profile before embryo transfer.<br /><br><br /><br>The main study endpoint is:<br /><br>• Recurrent implantation failure</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>• Blood parameters: anticardiolipin antibodies, lupus anticoagulant, Factor V<br /><br>Leiden mutation, prothrombin gene mutation, deficiencies in protein S, protein<br /><br>C, and antithrombin, TSH (when abnormal FT4 as well), basal FSH.<br /><br>• The pulsatility index of the a. uterina before ET.<br /><br><br /><br>The secondary study endpoint are:<br /><br>• Number of embryos transferred<br /><br>• Number of embryo transfers</p><br>