Phase 2 Completed N=41 Single-blind Treatment

Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility

Recurrent Pregnancy Loss · Unexplained Infertility

Source: ClinicalTrials.gov NCT03401918 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcomePrimary: Abnormal Microbiome Bacterial Sequencing

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.

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	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.