Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04537416 |
| Other study ID # |
2017P001215/PHS |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2018 |
| Est. completion date |
July 30, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Brigham and Women's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
Study Design:
Over a 2-year period, we will perform a retrospective observational cohort analysis of 1000
patients referred to the BWH Center for Infertility and Reproductive Surgery for evaluation
of recurrent pregnancy loss. This cohort will include a retrospective analysis of 200
infertility patients referred to Dr. Piazza's Cardiovascular Medicine clinic for evaluation
of thrombophilia.
We will also enroll prospectively for 18 months patients referred to the BWH Center for
Infertility and Reproductive Surgery for evaluation of recurrent pregnancy loss.
Study Population:
We will include a study population that is representative of the ethnic and racial diversity
of women who receive care at BWH. We will not enroll post-menopausal women, men or children
because recurrent pregnancy loss specifically affects women of child-bearing potential. We do
not plan to enroll pregnant women because we are specifically focused on women with recurrent
pregnancy loss presenting for assisted reproductive therapy.
Retrospective Cohort:
For our retrospective analysis we will include 800 consecutive women at least 18 years old
but not greater than 40 years old with a chief complaint of recurrent pregnancy loss referred
to the BWH Center for Infertility and Reproductive Surgery and 200 consecutive patients
referred to Dr. Piazza's Cardiovascular Medicine clinic for evaluation of thrombophilia as a
cause of recurrent pregnancy loss. This will provide a total of 1000 patients for the
retrospective cohort analysis.
Study Inclusion Criteria
1. Age 18-40 years
2. 2 or more pregnancy losses (including chemical pregnancies but not ectopic pregnancy)
3. Evaluated at the BWH Center for Infertility and Reproductive Surgery or the Watkins
Cardiovascular Clinic
Study Exclusion Criteria
1. Infertility due to uterine factors (such as Asherman's Syndrome)
2. Known translocation carrier
3. Prior venous thromboembolism on anticoagulation
4. Abnormal uterine cavity on hysterosalpingogram/hysteroscopy
Prospective Cohort:
For the 18-month prospective cohort analysis, we will enroll consecutive patients evaluated
at the BWH Center for Infertility and Reproductive Surgery for recurrent pregnancy loss.
Study Inclusion Criteria
1. Age 18-40 years
2. 2 or more pregnancy losses (including chemical pregnancies but not ectopic pregnancy)
3. Evaluated at the BWH Center for Infertility and Reproductive Surgery
Study Exclusion Criteria
1. Infertility due to uterine factors (such as Asherman's Syndrome)
2. Known translocation carrier
3. Prior venous thromboembolism on anticoagulation
4. Abnormal uterine cavity on hysterosalpingogram/hysteroscopy
Study Procedures:
From the EPIC Electronic Health Record (EHR), we will record demographic characteristics,
comorbid conditions, details about the presentation of infertility, pregnancy losses, and
prior assisted reproductive treatments, thrombophilia panel results, treatments, and
outcomes, including successful pregnancies and deliveries. We will calculate the prevalence
of thrombophilia in patients referred to BWH Center for Infertility and Reproductive Surgery
for evaluation of recurrent pregnancy loss. We will describe the outcomes of patients
receiving prophylactic low-dose anticoagulation, including bleeding, thrombotic events, and
live births. We will perform multivariable regression analyses to answer additional key
questions of predictors of thrombophilia as a cause of recurrent pregnancy loss and
successful treatment of infertility due to thrombophilia.
The proposed retrospective and prospective cohort analysis will provide information about the
standard of care at BWH for patients with recurrent pregnancy loss who may have
thrombophilia. The registry will not change the standard of care for diagnosis and treatment
of the patients at BWH in any way. The registry will not mandate any testing or treatments.
There will be no required study visits, follow-up, or subject or provider contact.
Data Analysis Plan:
We will describe the results of patients receiving prophylactic anticoagulation, including
frequency of bleeding and thrombotic events. We will calculate the prevalence of
thrombophilia in patients referred to BWH Center for Infertility and Reproductive Surgery for
evaluation of recurrent pregnancy loss. We will perform multivariable regression analyses to
answer additional key questions of predictors of thrombophilia as a cause of recurrent
pregnancy loss, chemical pregnancy after assisted reproductive therapy, and successful
treatment of infertility due to thrombophilia.
