Overview

Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility

Status:
Recruiting
Trial end date:
2026-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Stanford University
Collaborator:
Instituto Valenciano de Infertilidad, IVI VALENCIA
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Progesterone
Criteria
Inclusion/Exclusion Criteria:

1. 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

2. 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

3. 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