Status:
COMPLETED
Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Instituto Valenciano de Infertilidad, IVI VALENCIA
Conditions:
Recurrent Pregnancy Loss
Unexplained Infertility
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if patients with recurrent pregnancy loss or unexplained infertility have an altered uterine gene expression or uterine microbiome (micro-organism composition...
Detailed Description
Recurrent pregnancy loss and unexplained infertility are emotional and difficult diagnoses. Despite a thorough medical investigation, many cases of recurrent pregnancy loss and infertility remain unex...
Eligibility Criteria
Inclusion
- Inclusion/Exclusion Criteria:
- Recurrent Pregnancy Loss
- Inclusion:
- Age 18-45
- 3 or more SABs including biochemical pregnancies OR 2 or more SABs if one is documented to be euploid
- Exclusion:
- irregular menstrual cycles
- Submucosal fibroid \>3cm
- Stage 3-4 endometriosis
- BMI \>40
- IUD within the last 3 months
- Unexplained infertility Patients
- Inclusion:
- TTC x \>= 1 year
- At least one SA with TMS \>10 mil within last 2 years
- At least one patent fallopian tube documented by HSG or SHG
- Cycle length 25-35 days
- Exclusion:
- Irregular menstrual cycles
- Submucosal fibroid \>3cm
- Stage 3-4 endometriosis
- BMI \>40
- IUD within the last 3 months
- Less then 2 SABs including biochemical pregnancies
- Healthy control patients
- Inclusion:
- Patients who present for fertility preservation, sex selection, same sex couples needing fertility care, preconception counseling
- 1 or more live births
- Exclusion:
- Irregular menstrual cycles
- Submucosal fibroid \>3cm
- Stage 3-4 endometriosis
- BMI \>40
- IUD within the last 3 months
- Less then 2 SABs including biochemical pregnancies
- No history of RPL or infertility
Exclusion
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03401918
Start Date
August 1 2017
End Date
July 1 2021
Last Update
April 1 2025
Active Locations (1)
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1
Reproductive Endocrinology and Infertility Center at Stanford University
Sunnyvale, California, United States, 94087