Fertility, Hypercoagulability, and Inflammation (FREYA) Registry

NCT04537416 | Active Not Recruiting

• 1 other identifier: 2017P001215/PHS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

A PubMed search of "thrombophilia" and "infertility" yields only 98 articles, the majority found in foreign medical journals and subspecialty journals with narrow readerships. Outside of Assisted Reproduction Clinics at academic medical centers, health care providers have limited awareness of the literature supporting thrombophilia evaluation and treatment in patients with recurrent pregnancy loss. As a result, women may suffer through years of repeated miscarriages before a thrombophilia evaluation is performed. By the time thrombophilia has been diagnosed as the cause of recurrent pregnancy loss, couples have often exhausted their personal savings on costly assisted reproductive therapies and present frustrated and psychologically exhausted. In this study, we will evaluate the frequency of thrombophilia as a cause of recurrent pregnancy loss and provide insights into our patient care experience at BWH.

Conditions

Thrombophilia

Outcome Measures

Primary Outcomes (1)

• Frequency of laboratory diagnosed thrombophilia

  Laboratory diagnosed acquired or inherited thrombophilia

  1 year

Study Arms (1)

Women with recurrent pregnancy loss

consecutive women at least 18 years old but not greater than 40 years old with a chief complaint of recurrent pregnancy loss

Other: No intervention

Interventions

No intervention OTHER

No intervention

Women with recurrent pregnancy loss

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: It is a study on miscarriage. Hence can only be women.
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women at least 18 years old but not greater than 40 years old with a chief complaint of recurrent pregnancy loss

You may qualify if:

• Age 18-40 years
• or more pregnancy losses (including chemical pregnancies but not ectopic pregnancy)
• Evaluated at the BWH Center for Infertility and Reproductive Surgery or the Watkins Cardiovascular Clinic

You may not qualify if:

• Infertility due to uterine factors (such as Asherman's Syndrome)
• Known translocation carrier
• Prior venous thromboembolism on anticoagulation
• Abnormal uterine cavity on hysterosalpingogram/hysteroscopy

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Thrombophilia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Thrombosis Research Group

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 3, 2020
• Study Start: April 1, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)