Recruiting

Observational Study

Sponsor:

Shady Grove Fertility Reproductive Science Center

Code:

NCT01800513

Conditions

Implantation Failure

Infertility

Eligibility Criteria

Sex: Female

Age: 18 - 37

Healthy Volunteers: Not accepted

Interventions

Endometrial Biopsy

Sham Procedure

Study Details

Brief 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.

Conditions

Implantation Failure

Infertility

Study ID

NCT01800513

Start date

Feb, 2013

Status verified date

Feb, 2013

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 37

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women age 18-37
  • One or more previous implantation failures with autologous fresh or frozen blastocyst transfer
  • Undergoing fresh autologous IVF cycle
  • No other current uterine (i.e.: uterine fibroids, polyps), hematologic, or genetic causes for infertility and implantation failure
  • One or more good quality blastocyst(s) available for transfer

Exclusion Criteria:

  • Those unable to comprehend the investigational nature of the proposed study
  • Positive pregnancy test
  • Possible causes for impaired implantation (systemic disease, endometriosis, ultrasound evidence of current hydrosalpinx, uterine polyps, uterine myomas (fibroids), uterine cavity malformations or Asherman's syndrome)
  • Poor responders, defined as FSH >12 on day 3 or less than 4 follicles on a previous IVF cycle
  • BMI >30 or <18

Study Design

Enrollment

254 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Endometrial Biopsy

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.

sham comparator: Control

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.

Interventions

Endometrial Biopsy

Sham Procedure

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Erin F Wolff, M.D.

wolffe@mail.nih.gov

Locations

Shady Grove Fertility Reproductive Science Center

Recruiting

Rockville, Maryland, United States, 20850

More Information

Sponsor

Shady Grove Fertility Reproductive Science Center

Last update posted

Feb 27, 2013

Last verified

Feb, 2013

Keywords

  • Implantation Failure
  • In-vitro Fertilization
  • Infertility
  • Endometrial Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shady Grove Fertility Reproductive Science Center on 2013-02-27.