NCT01800513

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

February 21, 2013

Last Update Submit

February 25, 2013

Conditions

Implantation FailureInfertility

Keywords

Implantation FailureIn-vitro FertilizationInfertilityEndometrial Biopsy

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measurement in this study is clinical pregnancy rate, which is defined as identification of a fetal heart beat on ultrasound.

    8-10 weeks after embryo transfer

Secondary Outcomes (5)

  • implantation rate

    8-10 weeks after embryo transfer

  • miscarriage rate

    2 years

  • multiple gestation rate

    at delivery

  • endometrial thickness during stimulation

    during stimulation

  • Live Birth rate

    10 months after IVF cycle

Study Arms (2)

Endometrial Biopsy

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Endometrial BiopsyPROCEDURE
Also known as: Endometrial Pippelle Biopsy Catheter
Endometrial Biopsy
Sham ProcedurePROCEDURE
Control

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shady Grove Fertility Reproductive Science Center

Rockville, Maryland, 20850, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Erin F Wolff, M.D.

    Shady Grove Fertility

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin F Wolff, M.D.

CONTACT

wolffe@mail.nih.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
REI Clinical Fellow

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 27, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

US(1)