Endometrial Biopsy Prior to IVF in Those Patients With Prior Implantation Failure
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 37 |
| Updated: | 4/2/2016 |
| Start Date: | February 2013 |
| End Date: | December 2015 |
| Contact: | Erin F Wolff, M.D. |
| Email: | wolffe@mail.nih.gov |
EVAULATION OF IMPLANTATION AND PREGNANCY AFTER ENDOMETRIAL INJURY VIA ENDOMETRIAL PIPELLE BIOPSY IN THE CYCLE PRIOR TO IVF: A RANDOMIZED, SINGLE-BLINDED, CONTROLLED TRIAL.
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.
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.
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.
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
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