Phase 2
N=41
Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility
Recurrent Pregnancy Loss · Unexplained Infertility
Bottom Line
View on ClinicalTrials.gov: NCT03401918 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Abnormal Microbiome Bacterial Sequencing
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Uterine ERA and microbiome testing (Diagnostic_test); Oral antibiotics and vaginal probiotics (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abnormal Microbiome Bacterial Sequencing |
— | — |
| PRIMARY Abnormal Endometrial Receptivity Array |
— | — |
| PRIMARY Normalized Microbiome Bacterial Sequencing |
— | — |
| PRIMARY Normalized Endometrial Receptivity Array |
— | — |
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) during the window of embryo implantation. Furthermore we would like to assess for women with an abnormal uterine gene expression whether vaginal progesterone medication improves or alters gene expression and for women with an abnormal microbiome whether antibiotic treatment followed by probiotic treatment normalizes the microbiome.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03401918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.