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Endometrial Biopsy for Infertility (EMBX/IVF Trial)

N/A
Waitlist Available
Led By Erin F Wolff, M.D.
Research Sponsored by Shady Grove Fertility Reproductive Science Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

EMBX/IVF Trial Summary

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.

Eligible Conditions
  • Infertility
  • Implantation Failure

EMBX/IVF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The measurement in this study is clinical pregnancy rate, which is defined as identification of a fetal heart beat on ultrasound.
Secondary outcome measures
Live Birth rate
Endometriosis
implantation rate
+2 more

EMBX/IVF Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Endometrial BiopsyExperimental Treatment1 Intervention
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.
Group II: ControlPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endometrial Biopsy
2014
Completed Phase 4
~530

Find a Location

Who is running the clinical trial?

Shady Grove Fertility Reproductive Science CenterLead Sponsor
6 Previous Clinical Trials
2,665 Total Patients Enrolled
6 Trials studying Infertility
2,665 Patients Enrolled for Infertility
Erin F Wolff, M.D.Principal InvestigatorShady Grove Fertility

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Shady Grove Fertility Reproductive Science Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Endometrial Biopsy Prior to IVF in Those Patients With Prior Implantation Failure
Ryan Heitmann 2013. "Endometrial Biopsy Prior to IVF in Those Patients With Prior Implantation Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01800513.
All > Ivf
~21 spots leftby Apr 2025
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