An interventional study of Endometrial Biopsy and Sham Procedure in Implantation Failure and Infertility, sponsored by Shady Grove Fertility Reproductive Science Center. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2013-02-27.
Sponsored by Shady Grove Fertility Reproductive Science Center · Not applicable, Interventional, and Treatment
This proposed research is a single center, prospective, single-blinded, randomized controlled trial, designed to evaluate IVF pregnancy outcomes following endometrial injury in 254 patients with implantation failure. Patients will be identified during their work-up and treatment at Shady Grove Fertility Reproductive Science Center. Only Shady Grove patients are eligible for the study. The investigators hypothesize in patients with one or more previous failed day 5 blastocyst transfers, injury to the endometrium via endometrial biopsy will improve clinical pregnancy outcomes compared to controls.
Despite advances in assisted reproductive technologies; implantation failure in patients undergoing in-vitro fertilization (IVF) is frequent. Unfortunately, few treatments exist except for the use of a gestational carrier. There have been a number of recent clinical studies demonstrating that local injury to the endometrium results in improved clinical pregnancy outcomes for patients with a history of implantation failure. However, not all studies have shown a beneficial effect, and those demonstrating benefit have been limited by small sample sizes, and considerable heterogeneity in the procedures and populations evaluated. A recent meta-analysis synthesized the available data concluded that a large, prospective, well-designed randomized trial is desperately needed to definitively assess this new possible treatment. If these preliminary findings from previous trials are confirmed, this practice could be applied in the clinical setting to help patients suffering from repeated implantation failures.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 254 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Shady Grove Fertility Reproductive Science Center is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Subjects will have a vaginal speculum placed and visualization of the cervix will be obtained. The cervix will be cleaned with betadine (or hibiclens for those with an iodine allergy). Those randomized to the treatment arm (endometrial biopsy) will have an endometrial pipelle (Endocell, Wallach, Orange, Connecticut) inserted gently through the cervix into the uterus. Two passes will be performed with the pipelle catheter. For each pass the catheter will be rotated and scraped 4 times, once in each quadrant.
Procedure: Endometrial Biopsy
Those randomized to the control group will have a small cotton swab placed gently into the cervix. No tissue will be obtained with this method. The randomization to a placebo control is necessary to prove that any positive effects seen are due to the biopsy and not just random chance.
Procedure: Sham Procedure
Also known as: Endometrial Pippelle Biopsy Catheter
The primary outcome measurement in this study is clinical pregnancy rate, which is defined as identification of a fetal heart beat on ultrasound.
Time frame: 8-10 weeks after embryo transfer
implantation rate
Time frame: 8-10 weeks after embryo transfer
miscarriage rate
Time frame: 2 years
multiple gestation rate
Time frame: at delivery
endometrial thickness during stimulation
Time frame: during stimulation
Live Birth rate
Time frame: 10 months after IVF cycle
This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Shady Grove Fertility Reproductive Science Center