Genomics and Microbiome Investigation in Cases of Recurrent Pregnancy Losses

NCT06604338 | Recruiting

• 2 other identifiers: 202105755364132100005327
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Recurrent pregnancy losses (RPL) are characterized by the occurrence of more than one spontaneous pregnancy loss. It is caused by different known factors, but about half of the cases remain without an explanation. Efforts are being done in the scientific community to solve this cases. In this study, the investigators aim to investigate genetic factors that might predispose to RPL, as well as the influence of the uterine microbiota (microorganisms that normally live in the uterus of women).

Conditions

Recurrent Pregnancy Loss(RPL)

Keywords

Miscarriage; Recurrent miscarriage; Abortion; Recurrent abortion; Genetic susceptibility; Microbiome

Outcome Measures

Primary Outcomes (2)

• Microbiome

  The participants microbiome will be evaluated aiming to compare the species profile between cases and controls. The bacteria present in the microbiome will be described at the genus and species level.

  At the time of enrollment

• Exome

  The participants exomes will be evaluated to look for variants in specific genes, aiming to identify rare variants that will be compared with frequencies from population genomic databases. The impact of the identified variants on proteins will be assessed through in silico functional predictors.

  At the time of enrollment

Study Arms (2)

RPL group

The RPL group will include women with a history of at least two spontaneous pregnancy losses, regardless of whether they have living children, and whose etiology for the pregnancy losses was not determined by the care team's protocols.

Diagnostic Test: Exome test; Diagnostic Test: Microbiota analysis

Control group

Women with at least two full-term pregnancies and no history of difficulty getting pregnant, pregnancy loss or other infertility factors will be enrolled in the control group.

Diagnostic Test: Microbiota analysis

Interventions

Exome test DIAGNOSTIC_TEST

An exome will be performed on the participants of RPL group.

RPL group

Microbiota analysis DIAGNOSTIC_TEST

A cervical microbiota analysis will be performed in the RPL and control groups.

Control group; RPL group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who seek the Gynecology and Obstetrics Service of the Hospital de Clínicas de Porto Alegre (HCPA) for care and investigation of causes of infertility or for exams not related to this condition will be included in the study.

You may qualify if:

• RPL group: history of at least two spontaneous pregnancy losses, regardless of whether they have living children, and whose etiology for the pregnancy losses was not determined by the care team\'s protocols;
• Control group: at least two full-term pregnancies and no history of difficulty getting pregnant, pregnancy loss or other infertility factors.

You may not qualify if:

• RPL group: less than two spontaneous pregnancy losses and those with a known cause for repeated pregnancy losses;
• Control group: N/A

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS): collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and cervical samples

MeSH Terms

Conditions

Abortion, Spontaneous; Abortion, Habitual; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucas Rosa Fraga, PhD, Professor

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Rosa Fraga, PhD, Professor

CONTACT

+555133597661; lrfraga@hcpa.edu.br

Luiza Pretto, PhD Student

CONTACT

+555133597661; luizapretto@hcpa.edu.br

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: April 14, 2023
• Primary Completion: July 5, 2024
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BR (1)