Recurrent Pregnancy Loss(RPL)NCT06604338
Genomics and Microbiome Investigation in Cases of Recurrent Pregnancy Losses
An observational study of Recurrent Pregnancy Loss(RPL), run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Recurrent Pregnancy Loss(RPL)
- What is being tested?
- Exome test and Microbiota analysis
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Apr 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- RPL group: less than two spontaneous pregnancy losses and those with a known cause for repeated pregnancy losses;
- Control group: N/A
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90410-000
Lucas Rosa Fraga, PhD, Professor, +555133597661, lrfraga@hcpa.edu.br
Luiza Pretto, PhD Student, +555133597661, luizapretto@hcpa.edu.br
About this study
Official title: Evaluation of Predisposing Factors for Idiopathic Recurrent Pregnancy Losses: a Study Using a Genomic and Microbiota Approach
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).
Read the detailed description
Recurrent pregnancy losses (RPL) are adverse reproductive outcomes characterized by the occurrence of more than one spontaneous pregnancy loss. It is estimated that RPL occurs in 1 to 5% of couples in reproductive period and is caused by different known factors. Despite this, around half of the cases remain without a defined etiology. In this context, efforts are being done in the scientific community to elucidate idiopathic cases. Among them, robust genomic investigations, such as exome sequencing, stand out for maximizing the chances of identifying causative gene variants rather than a gene-specific approach. Another front of study to understand the factors that modulate complex etiology conditions such RPL is the characterization of the microbiota of different anatomical sites. Each human anatomical site presents a distinct microbiota selected through a long co-evolutionary process and its individual and pathological variability can lead to functional repercussions. Therefore, the aim of this study is to investigate factors predisposing to recurrent pregnancy loss through a genomic evaluation and characterization of the uterine microbiota of patients affected by RPL. To achieve this, two approaches will be conducted: a genomic approach, where the exome of women with RPL will be analyzed and compared with population genomic databases; and a etagenomic approach, where the characterization of the uterine microbiota of women with RPL will be performed and compared with that of fertile women. Using the data produced in this study, the investigators hope to be able to understand more broadly how the genome influences the predisposition to RPL and how changes in certain marker genes can lead to an increased risk for the occurrence of this reproductive condition. Furthermore, based on analyzes of the uterine microbiota, the investigators hope to be able to understand how the variability of microorganisms present in this organ acts during pregnancy, especially in cases of RPL. The results of the investigations proposed in this project will help to understand the predisposing factors to RPL and may lead to the development of new investigative approaches, such as the design of genetic panels and analyzes of the uterine microbiota, which may have an impact on the clinical management of the condition in the future.
- Conditions
- Recurrent Pregnancy Loss(RPL)
- Being tested
- Exome test, Microbiota analysis
- Keywords
- Miscarriage, Recurrent miscarriage, Abortion, Recurrent abortion, Genetic susceptibility, Microbiome
- Medical subject headings
- Abortion, Spontaneous, Abortion, Habitual, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exome testDiagnostic test
An exome will be performed on the participants of RPL group.
Microbiota analysisDiagnostic test
A cervical microbiota analysis will be performed in the RPL and control groups.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Microbiota analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Apr 2023
- Primary completion5 Jul 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy Loss(RPL)Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Lucas Rosa Fraga, PhD, Professor, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604338
- Sponsor's protocol ID
- 20210575
- Other IDs
- 5364132100005327
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predisposing Factors for Idiopathic Recurrent Pregnancy Losses: a Study Using a Genomic and Microbiota Approach
- ClinicalTrials.gov ID
- NCT06604338
- Acronym / sponsor ID
- 20210575
- Conditions
- Recurrent Pregnancy Loss(RPL)
- Keywords
- Miscarriage, Recurrent miscarriage, Abortion, Recurrent abortion, Genetic susceptibility, Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Recurrent pregnancy losses (RPL) are adverse reproductive outcomes characterized by the occurrence of more than one spontaneous pregnancy loss. It is estimated that RPL occurs in 1 to 5% of couples in reproductive period and is caused by different known factors. Despite this, around half of the cases remain without a defined etiology. In this context, efforts are being done in the scientific community to elucidate idiopathic cases. Among them, robust genomic investigations, such as exome sequencing, stand out for maximizing the chances of identifying causative gene variants rather than a gene-specific approach. Another front of study to understand the factors that modulate complex etiology conditions such RPL is the characterization of the microbiota of different anatomical sites. Each human anatomical site presents a distinct microbiota selected through a long co-evolutionary process and its individual and pathological variability can lead to functional repercussions. Therefore, the aim of this study is to investigate factors predisposing to recurrent pregnancy loss through a genomic evaluation and characterization of the uterine microbiota of patients affected by RPL. To achieve this, two approaches will be conducted: a genomic approach, where the exome of women with RPL will be analyzed and compared with population genomic databases; and a etagenomic approach, where the characterization of the uterine microbiota of women with RPL will be performed and compared with that of fertile women. Using the data produced in this study, the investigators hope to be able to understand more broadly how the genome influences the predisposition to RPL and how changes in certain marker genes can lead to an increased risk for the occurrence of this reproductive condition. Furthermore, based on analyzes of the uterine microbiota, the investigators hope to be able to understand how the variability of microorganisms present in this organ acts during pregnancy, especially in cases of RPL. The results of the investigations proposed in this project will help to understand the predisposing factors to RPL and may lead to the development of new investigative approaches, such as the design of genetic panels and analyzes of the uterine microbiota, which may have an impact on the clinical management of the condition in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPL group | – | Diagnostic Test: Exome test, Diagnostic Test: Microbiota analysisThe 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. |
| Control group | – | Diagnostic Test: Microbiota analysisWomen 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- RPL group: less than two spontaneous pregnancy losses and those with a known cause for repeated pregnancy losses;
- Control group: N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exome testAn exome will be performed on the participants of RPL group. | Diagnostic test | RPL group |
| Microbiota analysisA cervical microbiota analysis will be performed in the RPL and control groups. | Diagnostic test | Control group, RPL group |
Primary outcome
Microbiome
Time frame: At the time of enrollment
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.
Exome
Time frame: At the time of enrollment
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Not yet recruiting
Noninvasive Implantation Potential vs Morphology-Based Selection in IVF Single Blastocyst Transfer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Rosa Fraga, PhD, Professor principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pregnancy Loss(RPL), run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas Rosa Fraga, PhD, Professor (+555133597661, lrfraga@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome (time frame: At the time of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.