Endometrial Biopsy Prior to IVF in Those Patients With Prior Implantation Failure

Infertility Clinical Trial

— EMBX/IVF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01800513
• Other study ID #: SGFRSC EMBX 2013
• Status: Recruiting
• Phase: N/A
• First received: February 21, 2013
• Last updated: February 25, 2013
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2013
• Source: Shady Grove Fertility Reproductive Science Center
• Contact: Erin F Wolff, M.D.
• Email: wolffe[@]mail.nih.gov
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 254
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Implantation Failure
• Infertility

Intervention

Procedure:
• Endometrial Biopsy

• Sham Procedure

Locations

Country	Name	City	State
United States	Shady Grove Fertility Reproductive Science Center	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Shady Grove Fertility Reproductive Science Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	implantation rate		8-10 weeks after embryo transfer	No
Secondary	miscarriage rate		2 years	No
Secondary	multiple gestation rate		at delivery	No
Secondary	endometrial thickness during stimulation		during stimulation	No
Secondary	Live Birth rate		10 months after IVF cycle	No

External Links

•   Shady Grove Fertility Home Page