Consortia For Infertility and Reproductive Medicine (ConFIRM) Clinical Trial Program

Note: ConFIRM replaces the Reproductive Medicine Network (RMN), which NICHD funded from 1990 to 2020. The RMN Investigator Group still meets and publishes manuscripts with primary and secondary data. The RMN Data Coordination Center at the Yale Collaborative Center for Statistics in Science maintains the RMN website external link, including information on RMN infertility trials external link. Data from RMN studies are available in NICHD’s Data and Specimen Hub (DASH).

Overview

Infertility, defined as the inability to conceive after 12 months of trying (or after 6 months for those older than 35), affects approximately 7% to 15% of reproductive-age couples. Most interventions to treat infertility are empirical, with insufficient evidence-based research to support the approach. Well-designed multisite clinical trials are essential to developing high-quality evidence that advances diagnosis and/or treatment of infertility.

ConFIRM is a collection of collaborative consortia consisting of two or more linked clinical sites that address important questions in male and female infertility and that translate new discoveries into clinical practice. Currently, the program includes three clinical trials and their respective consortia. Each is investigating an important topic in reproductive health, utilizing a common clinical trial protocol implemented across sites with rigor, adequate sample size, and diversity to provide answers more rapidly than individual sites acting alone. 

ConFIRM addresses important questions in the field of reproductive medicine requiring coordinated multisite clinical trials. Regardless of the outcomes, the findings promise to affect clinical practice.

Topic Areas and Consortia Members

ConFIRM includes the following topic areas/clinical trials and consortia members:

Endometrial Environment (Uterine Receptivity)/Implantation and Effects on Downstream Obstetrical Outcomes such as Preeclampsia

This consortium is studying the comparative effectiveness and safety of two commonly used clinical approaches for achieving endometrial receptivity for frozen embryo transfer. 

Consortium Members

  • Johns Hopkins University: Principal Investigators (PIs): Valerie Baker, M.D., and James Segars, M.D.
  • University of Oklahoma Health Sciences Center: PI: Karl Hansen, M.D., Ph.D.
  • Stanford University: PIs: Ruth Lathi, M.D., and Virginia Winn, M.D.

Optimizing Live Birth Outcomes in Women with Endometriosis-Associated Infertility

Although in vitro fertilization (IVF) is necessary in most cases of infertility associated with endometriosis, knowledge gaps remain with regard to optimal treatment. This consortium is investigating the treatment of endometriosis with an oral gonadotropin-releasing hormone (GnRH) antagonist prior to IVF to determine the effects on live birth outcomes. 

Consortium Members

  • Yale University: PIs: Hugh Taylor, M.D., and Heping Zhang, Ph.D.
  • Northwestern University at Chicago: PI: Jared C. Robins, M.D.
  • University of North Carolina at Chapel Hill: PI: Steven Young, M.D., Ph.D.
  • University of Colorado Denver: PI: Nanette Santoro, M.D.

Evaluation of a Novel Non-Hormonal Treatment of Uterine Fibroids that Does Not Interfere with Desired Fertility

Uterine fibroids are a common condition in aging women, which is problematic as the age at first birth rises. Moreover, the incidence of uterine fibroids is higher in Black versus White women, creating an additional health disparity. Uterine fibroids are associated with infertility in cases with distortion of the uterine cavity and with increasing size. Medical treatments to reduce size and symptoms of uterine fibroids often interfere with a woman’s fertility. This consortium is investigating a novel nonpharmacologic substance, EGCG/green tea extract, that is known not to interfere with the Hypothalamic-Pituitary-Ovarian axis and that effectively reduced fibroid size in a previous, but small study. The identification of a nonhormonal fertility-friendly therapy would have significant public health impact.

Consortium Members

  • University of Illinois Chicago: PI: Ayman Al-Hendy, M.D.
  • University of Chicago: PI: Maritza Gonzalez, M.D.
  • Yale University: PIs: Hugh Taylor, M.D., and Heping Zhang, Ph.D.
  • Johns Hopkins University: PIs: Valerie Baker, M.D., and James Segars, M.D.

More Information

NICHD Contact (for both ConFIRM and RMN): Esther Eisenberg

top of pageBACK TO TOP