Recurrent Pregnancy Loss Clinical Trial
Official title:
Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility
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.
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 unexplained. Understanding endometrial factors that may contribute to these diseases may lead to improved treatment options in the future. 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. A standard evaluation for infertility includes a uterine cavity evaluation, evaluation for ovarian reserve testing, and for patients with recurrent pregnancy loss parental testing for uterine infection, chromosome analysis, autoimmune and thyroid screening. This standard workup, however, does not include a molecular or microbial assessment of the endometrium. Endometrial factors may contribute to unexplained infertility or recurrent pregnancy loss however the extent of this is unknown. We are recruiting patients who have recurrent pregnancy loss, unexplained infertility, and healthy control patients who have had a term delivery in order to compare differences between these groups. Subjects will undergo an endometrial biopsy that will specifically test the receptivity of your endometrium as well as identify the bacterial composition of the uterine environment (microbiome). The endometrial receptivity array and microbiome testing will be performed at no cost. The endometrial receptivity array provides information on the receptivity of a patient's endometrium to the implantation of an embryo. This may yield additional information regarding the etiology of a patient's infertility and/or recurrent pregnancy loss. If this testing is abnormal we may repeat the biopsy after vaginal progesterone supplementation to see if this normalizes the results. If the microbiome is abnormal we may repeat the biopsy after oral antibiotics and vaginal probiotics to see if this normalizes your microbiome results. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04718233 -
Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss
|
Phase 2 | |
Recruiting |
NCT01946945 -
Comparison of Standard ART Practice vs. Trophectoderm Biopsy and Whole Chromosome Analysis
|
Phase 2 | |
Completed |
NCT02572154 -
Sperm DNA Fragmentation in Recurrent Pregnancy Loss
|
N/A | |
Completed |
NCT03174951 -
Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss
|
Phase 2 | |
Recruiting |
NCT05444283 -
Genomic Predictors of Recurrent Pregnancy Loss
|
||
Active, not recruiting |
NCT04621773 -
Live Birth Rate in Patients With Unexplained Recurrent Pregnancy Loss
|
||
Recruiting |
NCT02990403 -
The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
|
Phase 4 | |
Recruiting |
NCT02990390 -
The Epidemiology of Recurrent Spontaneous Abortion Associated With Thrombophilla
|
N/A | |
Not yet recruiting |
NCT05612620 -
Elucidating the Microbiome in Patients With Recurrent Pregnancy Loss
|
||
Not yet recruiting |
NCT05520112 -
Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells
|
Phase 1/Phase 2 | |
Suspended |
NCT04397042 -
SCUBE-1 and Carotid Intima Media Thickness in Recurrent Pregnancy Loss
|
||
Not yet recruiting |
NCT05341856 -
Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients With URPL
|
Early Phase 1 | |
Recruiting |
NCT06007560 -
Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss
|
N/A | |
Completed |
NCT02386384 -
TNFα and MFG-E8: Novel Biomarkers to Predict Implantation Failure
|
N/A | |
Recruiting |
NCT01635426 -
Aspirin Versus Clopidogrel Effect on Uterine Blood Flow in Women With Unexplained Recurrent Miscarriages
|
Phase 2/Phase 3 | |
Suspended |
NCT01546350 -
Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH
|
Phase 2 | |
Completed |
NCT00721591 -
Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
|
N/A | |
Terminated |
NCT00564174 -
Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT
|
N/A | |
Completed |
NCT04455256 -
Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss
|
||
Not yet recruiting |
NCT05237843 -
Hydroxychloroquine in Unexplained Recurrent Pregnancy Loss
|
Phase 1 |