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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01800513
Other study ID # SGFRSC EMBX 2013
Secondary ID
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


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
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