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EVAULATION OF IMPLANTATION AND PREGNANCY AFTER ENDOMETRIAL INJURY VIA ENDOMETRIAL PIPELLE BIOPSY IN THE CYCLE PRIOR TO IVF: A RANDOMIZED, SINGLE-BLINDED, CONTROLLED TRIAL.


N/A
18 Years
37 Years
Open (Enrolling)
Female
Implantation Failure, Infertility

Thank you

Trial Information

EVAULATION OF IMPLANTATION AND PREGNANCY AFTER ENDOMETRIAL INJURY VIA ENDOMETRIAL PIPELLE BIOPSY IN THE CYCLE PRIOR TO IVF: A RANDOMIZED, SINGLE-BLINDED, CONTROLLED TRIAL.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

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.

Outcome Time Frame:

8-10 weeks after embryo transfer

Safety Issue:

No

Principal Investigator

Erin F Wolff, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shady Grove Fertility

Authority:

United States: Data and Safety Monitoring Board

Study ID:

SGFRSC EMBX 2013

NCT ID:

NCT01800513

Start Date:

February 2013

Completion Date:

December 2015

Related Keywords:

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

Name

Location

Shady Grove Fertility Reproductive Science Center Rockville, Maryland  20850