Clinical trial NCT01800513: Endometrial Biopsy Prior to IVF in Those Patients With Prior Implantation Failure
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implantation Failure
Infertility
Keywords: Implantation Failure
In-vitro Fertilization
Infertility
Endometrial Biopsy
Lead sponsor: Shady Grove Fertility Reproductive Science Center
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 254
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome measurement in this study is clinical pregnancy rate, which is defined as identification of a fetal heart beat on ultrasound.
timeFrame: 8-10 weeks after embryo transfer
Secondary outcomes:
measure: implantation rate
timeFrame: 8-10 weeks after embryo transfer
measure: miscarriage rate
timeFrame: 2 years
measure: multiple gestation rate
timeFrame: at delivery
measure: endometrial thickness during stimulation
timeFrame: during stimulation
measure: Live Birth rate
timeFrame: 10 months after IVF cycle
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Shady Grove Fertility Reproductive Science Center
state: Maryland
Study officials:
affiliation: Shady Grove Fertility
name: Erin F Wolff, M.D.
role: PRINCIPAL_INVESTIGATOR
References: