TNFα and MFG-E8: Novel Biomarkers to Predict Implantation Failure (NCT02386384) | Clinical Trial Compass
CompletedNot Applicable
TNFα and MFG-E8: Novel Biomarkers to Predict Implantation Failure
15 participantsStarted 2015-03
Plain-language summary
Question: Can implantation failure (IF) be predicted prior to in vitro fertilization (IVF)? A pilot, non-interventional, clinical study Prospective, controlled, cohort study
Who can participate
Age range21 Years – 35 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* women 21-35y
* with no contraindication to pregnancy
* on no hormonal contraception
* normal uterine cavity
* absence of hydrosalpinges
* normal ovarian reserve (FSH\<13 mIU/.ml or AMH\>1 ng/ml or normal antral follicular count\>10 total follicles \<10 mm in diameter, American Society for Reproductive Medicine-ASRM 2012).
* Three groups of patients will be enrolled: 10 fertile controls (C1-10: women who are participating in the donor egg program as egg donors), 10 with unexplained implantation failure (IF1-10: patients who have failed IVF cycles -failure of implantation following 2 or more cycles with transfer of embryos of good quality-at least 2 cleaving embryos with 6-8 cells, grades 1- 3 (scale 1-highest and 5-poorest morphology score), and normal uterus, and 10 with recurrent unexplained first trimester miscarriages (RM1-10: 2 consecutive miscarriages under 10 weeks, after spontaneous or IVF conceptions).
Exclusion Criteria:
* contraindication to pregnancy
* use of hormonal contraception
* abnormal uterine cavity
* hydrosalpinges
* abnormal karyotype.
* women who are pregnant or planning to get pregnant in the cycle in which they are participating in this study
* women who have had a hysterectomy (previous removal of your uterus)
* have a current medical condition, which, in the opinion of the investigator, would result in hazards to the subject, should she participate in the study or have a current medical condition which would potentially confo…
What they're measuring
1
concentration of MFG-E8 and TNFα in serum and in endometrial biopsies controls, IF and RM.