PERFORM

Trial ID or NCT#

NCT04107129

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to understand why some women are infertile (unable to conceive a child). The investigators hope to learn if an endometrial biopsy after egg retrieval is feasible for detecting biomarkers for endometriosis and predicting implantation and pregnancy rate after embryo transfer. This study design will provide for the first time, an opportunity to compare endometrial biopsy material from hyperstimulated (gonadotropin treated) subjects after egg retrieval. If successful, it would provide a new protocol for women with unexplained infertility or those with known endometriosis to avoid poor IVF outcomes.

Official Title

Predicting Endometrial Receptivity for Optimal Reproductive Management (PERFORM)

Eligibility Criteria

Ages Eligible for Study: 18 to 42
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Age - 18 to 422. AMH ≥ 13. Planning to undergo IVF with delayed embryo transfer4. Must have blastocyst(s) by day 6 that were biopsied for PGT-A5. BMI 18-35
    1. Exclusion Criteria:
  2. 1. Uterine fibroids \> 4 cm in size2. Polycystic ovary syndrome (PCOS) according with the Rotterdam criteria.3. Ovarian failure and subjects receiving donor oocytes/embryos4. Anti-cardiolipid and/or lupus anti-coagulant abnormalities by history5. Diabetes mellitus (Type I or Type II)6. Untreated hypothyroidism7. Hyperprolactinemia8. Uncorrected uterine anomaly
Exclusion Criteria:
  1. 1. Uterine fibroids \> 4 cm in size2. Polycystic ovary syndrome (PCOS) according with the Rotterdam criteria.3. Ovarian failure and subjects receiving donor oocytes/embryos4. Anti-cardiolipid and/or lupus anti-coagulant abnormalities by history5. Diabetes mellitus (Type I or Type II)6. Untreated hypothyroidism7. Hyperprolactinemia8. Uncorrected uterine anomaly

Investigator(s)

Ruth Bunker Lathi
Ruth Bunker Lathi
Obstetrician and Gynecologist (OB-GYN), Fertility specialist
Professor of Obstetrics and Gynecology (Reproductive Endocrinology and Infertility)

Contact us to find out if this trial is right for you.

Contact

Raquel Fleischmann, DVM
408-426-5586