EndometriosisNCT05824819
Endometriosis and Peritoneal Dysbiosis
A study testing Next Generation Sequencing (NGS) in people with Endometriosis and Infertility Unexplained, run by Jagiellonian University at 1 site in Poland.
Trial summary
Endometriosis is a complex clinical syndrome that impairs many aspects of a woman's life, characterized by a chronic estrogen-dependent inflammatory process, mainly affecting the pelvic organs, with ectopic presence of tissue analogous to the uterine mucosa (endometrium). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Infertility Unexplained
- What is being tested?
- Next Generation Sequencing (NGS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age 18-45 years
- indications for surgical treatment of endometriosis by laparoscopy and/or indications for invasive diagnostics by laparoscopy due to idiopathic infertility.
Who cannot join
- abdominal surgeries performed within 6 months prior hospitalisation
- active infection of the genital tract
- inflammatory bowel disease
- antibiotic therapy and use of probiotics within 3 months before surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Krakow, 31-501
Iwona M. Gawron, Ph.D., +48 12 4248570, iwona.gawron@uj.edu.pl
Robert Jach, Prof., +48 12 4248571, robert.jach@uj.edu.pl
About this study
Official title: "Is the Reduced Quality of Life of Women With Endometriosis the Result of Peritoneal Dysbiosis?"
Endometriosis is a complex clinical syndrome that impairs many aspects of a woman's life, characterized by a chronic estrogen-dependent inflammatory process, mainly affecting the pelvic organs, with ectopic presence of tissue analogous to the uterine mucosa (endometrium). Despite intensive research in the field of etiopathogenesis, its cause has not yet been determined, and treatment remains symptomatic. Endometriosis causes two main complications, i.e. pelvic pain syndrome and infertility. In recent years, thanks to the analysis of the human microbiome, it has become possible to deepen the knowledge of the physiological and pathological interactions between microorganisms inhabiting various body areas and the host. Bacteria may enter the peritoneal cavity in the mechanism of retrograde menstruation and translocate from the intestines, and then promote the development of local and systemic inflammation, leading to the symptoms of endometriosis. The study is to determine whether the presence of a specific intestinal, peritoneal and uterine microbiome correlates with endometriosis stage and whether its presence predisposes to increased pain or infertility. Concordance or divergence of bacterial populations inhabiting the peritoneal and uterine cavities could have clinical implications, i.e. the possibility of empirical antibiotic therapy in patients undergoing only endometrial aspiration biopsy and not opting for surgical treatment.
Read the detailed description
The main objective of the project is to analyze gut, peritoneal and uterine microbiome in women who undergo laparoscopy due to endometriosis (arm 1) or idiopathic infertility (arm 2). Detailed objectives are: i) analysis of the correlation between the composition of the intestinal, peritoneal and uterine microbiome with the stage of endometriosis according to ASRM, ii) qualitative comparison of the intestinal and peritoneal microbiome to the uterine cavity microbiome in women with endometriosis vs. idiopathic infertility, iii) analysis of the correlation between the composition of the intestinal, peritoneal and uterine microbiome with the intensity of pain and infertility, iv) comparing the quality of life in both arms and assessing its correlation with the local microbiome. Quality of life will be assessed in both arms using the SF-36 questionnaire, and then compared. The SF-36 self-reported questionnaire covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. The study group will consist of women of childbearing age, undergoing surgical treatment due to pelvic endometriosis or idiopathic infertility. Before the surgery, a stool sample will be taken for examination of intestinal microbiome. During scheduled laparoscopy, in addition to the planned procedure, which is the purpose of hospitalization, an endometrial aspiration biopsy will be performed and fluid from the peritoneal cavity and/or fluid from the ovarian cyst will be collected for analysis of the local microbiome. Biological materials (stool, peritoneal/ovarian cyst fluid, endometrial aspirate) will be secured and then subjected to molecular analysis using the Next Generation Sequencing (NGS) method. The stages will include: i) isolation of bacterial DNA from biological materials, ii) preparation of libraries for sequencing, including the performance of the PCR and nested-PCR methods on bacterial DNA isolates from the tested samples of biological materials, iii) purification of amplification products, indexing, validation of the concentration of amplicons, pooling and denaturation of libraries, iv) standardization and optimization of the procedure for the isolation of bacterial metagenomic DNA from biological materials from intestines, peritoneal cavity, uterine cavity and endometrial tissues, v) standardization of the nested-PCR method on bacterial DNA isolates from the tested biological materials, vi) submission of samples for sequencing. Sequencing data will be subjected to bioinformatics analysis to obtain bacterial profiles (the percentage composition of the local bacterial population by phyla and genera). The aim is to characterize the microbiome of the intestines, peritoneal and the uterine cavity in women undergoing surgical treatment for endometriosis or invasive diagnostics for idiopathic infertility, and to compare the bacterial populations in these locations, which may also provide information on the origin of bacteria in the peritoneal cavity.
- Conditions
- Endometriosis, Infertility Unexplained
- Being tested
- Next Generation Sequencing (NGS)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation Sequencing (NGS)Diagnostic test
Biological materials (stool, peritoneal/ovarian cyst fluid, endometrial aspirate) will be secured and then subjected to molecular analysis using the Next Generation Sequencing (NGS) method. The stages will include: i) isolation of bacterial DNA from biological materials, ii) preparation of libraries for sequencing, including the performance of the PCR and nested-PCR methods on bacterial DNA isolates from the tested samples of biological materials, iii) purification of amplification products, indexing, validation of the concentration of amplicons, pooling and denaturation of libraries, iv) standardization and optimization of the procedure for the isolation of bacterial metagenomic DNA from biological materials from intestines, peritoneal cavity, uterine cavity and endometrial tissues, v) standardization of the nested-PCR method on bacterial DNA isolates from the tested biological materials, vi) submission of samples for sequencing.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Active comparator | Women subjected to laparoscopy due to endometriosis. Before the procedure: collection of a stool sample for NGS testing (2 ml); During the procedure: collection of fluid/ washings from the peritoneal cavity (2 ml) and fluid from the endometrial cyst (2 ml), and collection of endometrial tissue by aspiration biopsy of the uterine cavity (1 ml) for NGS examination. Receives: Diagnostic Test: Next Generation Sequencing (NGS) |
| Idiopathic infertility | Active comparator | Women subjected to laparoscopy due to idiopathic infertility. Before the procedure: collection of a stool sample for NGS testing (2 ml); During the procedure: collection of fluid/ washings from the peritoneal cavity (2 ml) and collection of endometrial tissue by aspiration biopsy of the uterine cavity (1 ml) for NGS examination. Receives: Diagnostic Test: Next Generation Sequencing (NGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of intestinal, peritoneal and uterine microbiome in both study arms
Percentage composition of the local bacterial population by phyla and genera
Measured: up to 6 months
Secondary outcomes (4)
Relation of the composition of intestinal, peritoneal and uterine microbiome and endometriosis stage
Correlation between the percentage composition of the local bacterial population (by phyla and genera) and the ASRM endometriosis stage
Measured: up to 6 months
Relation of the uterine microbiome to the intestinal and peritoneal microbiome in women with endometriosis and idiopathic infertility
Correlation between the percentage composition of the uterine bacterial population (by phyla and genera) and the percentage composition of the intestinal and peritoneal microbiome (by phyla and genera)
Measured: up to 6 moths
Relation of intestinal, peritoneal and uterine microbiome and symptoms
Correlation between the percentage composition of local microbiomes (by phyla and genera) and the severity of pain symptoms on the Numeric Rating Scale (NRS from 0 - no pain to 10 - maximum pain) and the duration of infertility (in years)
Measured: up to 6 moths
Composition of intestinal, peritoneal and uterineand quality of life
Correlation between the percentage composition of local microbiomes (by phyla and genera) and the percentage result of the SF-36 questionnaire evaluating of 8 area of life on a scale from 0% - the worst quality to 100% - the best quality
Measured: up to 6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 May 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective tertiary single-centre cohort study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Robert Jach, Prof. Ph.D., Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824819
- Sponsor's protocol ID
- 1072.6120.24.2023
- Status last verified
- Apr 2025
- First submitted
- 22 Mar 2023
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Is the Reduced Quality of Life of Women With Endometriosis the Result of Peritoneal Dysbiosis?"
- ClinicalTrials.gov ID
- NCT05824819
- Acronym / sponsor ID
- 1072.6120.24.2023
- Conditions
- Endometriosis, Infertility Unexplained
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Apr 2023 (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.
Endometriosis is a complex clinical syndrome that impairs many aspects of a woman's life, characterized by a chronic estrogen-dependent inflammatory process, mainly affecting the pelvic organs, with ectopic presence of tissue analogous to the uterine mucosa (endometrium). Despite intensive research in the field of etiopathogenesis, its cause has not yet been determined, and treatment remains symptomatic. Endometriosis causes two main complications, i.e. pelvic pain syndrome and infertility. In recent years, thanks to the analysis of the human microbiome, it has become possible to deepen the knowledge of the physiological and pathological interactions between microorganisms inhabiting various body areas and the host. Bacteria may enter the peritoneal cavity in the mechanism of retrograde menstruation and translocate from the intestines, and then promote the development of local and systemic inflammation, leading to the symptoms of endometriosis. The study is to determine whether the presence of a specific intestinal, peritoneal and uterine microbiome correlates with endometriosis stage and whether its presence predisposes to increased pain or infertility. Concordance or divergence of bacterial populations inhabiting the peritoneal and uterine cavities could have clinical implications, i.e. the possibility of empirical antibiotic therapy in patients undergoing only endometrial aspiration biopsy and not opting for surgical treatment.
Detailed description
The main objective of the project is to analyze gut, peritoneal and uterine microbiome in women who undergo laparoscopy due to endometriosis (arm 1) or idiopathic infertility (arm 2). Detailed objectives are: i) analysis of the correlation between the composition of the intestinal, peritoneal and uterine microbiome with the stage of endometriosis according to ASRM, ii) qualitative comparison of the intestinal and peritoneal microbiome to the uterine cavity microbiome in women with endometriosis vs. idiopathic infertility, iii) analysis of the correlation between the composition of the intestinal, peritoneal and uterine microbiome with the intensity of pain and infertility, iv) comparing the quality of life in both arms and assessing its correlation with the local microbiome. Quality of life will be assessed in both arms using the SF-36 questionnaire, and then compared. The SF-36 self-reported questionnaire covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. The study group will consist of women of childbearing age, undergoing surgical treatment due to pelvic endometriosis or idiopathic infertility. Before the surgery, a stool sample will be taken for examination of intestinal microbiome. During scheduled laparoscopy, in addition to the planned procedure, which is the purpose of hospitalization, an endometrial aspiration biopsy will be performed and fluid from the peritoneal cavity and/or fluid from the ovarian cyst will be collected for analysis of the local microbiome. Biological materials (stool, peritoneal/ovarian cyst fluid, endometrial aspirate) will be secured and then subjected to molecular analysis using the Next Generation Sequencing (NGS) method. The stages will include: i) isolation of bacterial DNA from biological materials, ii) preparation of libraries for sequencing, including the performance of the PCR and nested-PCR methods on bacterial DNA isolates from the tested samples of biological materials, iii) purification of amplification products, indexing, validation of the concentration of amplicons, pooling and denaturation of libraries, iv) standardization and optimization of the procedure for the isolation of bacterial metagenomic DNA from biological materials from intestines, peritoneal cavity, uterine cavity and endometrial tissues, v) standardization of the nested-PCR method on bacterial DNA isolates from the tested biological materials, vi) submission of samples for sequencing. Sequencing data will be subjected to bioinformatics analysis to obtain bacterial profiles (the percentage composition of the local bacterial population by phyla and genera). The aim is to characterize the microbiome of the intestines, peritoneal and the uterine cavity in women undergoing surgical treatment for endometriosis or invasive diagnostics for idiopathic infertility, and to compare the bacterial populations in these locations, which may also provide information on the origin of bacteria in the peritoneal cavity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective tertiary single-centre cohort study
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | Active comparator | Diagnostic Test: Next Generation Sequencing (NGS)Women subjected to laparoscopy due to endometriosis. Before the procedure: collection of a stool sample for NGS testing (2 ml); During the procedure: collection of fluid/ washings from the peritoneal cavity (2 ml) and fluid from the endometrial cyst (2 ml), and collection of endometrial tissue by aspiration biopsy of the uterine cavity (1 ml) for NGS examination. |
| Idiopathic infertility | Active comparator | Diagnostic Test: Next Generation Sequencing (NGS)Women subjected to laparoscopy due to idiopathic infertility. Before the procedure: collection of a stool sample for NGS testing (2 ml); During the procedure: collection of fluid/ washings from the peritoneal cavity (2 ml) and collection of endometrial tissue by aspiration biopsy of the uterine cavity (1 ml) for NGS examination. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18-45 years
- indications for surgical treatment of endometriosis by laparoscopy and/or indications for invasive diagnostics by laparoscopy due to idiopathic infertility.
Key exclusion criteria (4 listed)
- abdominal surgeries performed within 6 months prior hospitalisation
- active infection of the genital tract
- inflammatory bowel disease
- antibiotic therapy and use of probiotics within 3 months before surgery
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 |
|---|---|---|
| Next Generation Sequencing (NGS)Biological materials (stool, peritoneal/ovarian cyst fluid, endometrial aspirate) will be secured and then subjected to molecular analysis using the Next Generation Sequencing (NGS) method. The stages will include: i) isolation of bacterial DNA from biological materials, ii) preparation of libraries for sequencing, including the performance of the PCR and nested-PCR methods on bacterial DNA isolates from the tested samples of biological materials, iii) purification of amplification products, indexing, validation of the concentration of amplicons, pooling and denaturation of libraries, iv) standardization and optimization of the procedure for the isolation of bacterial metagenomic DNA from biological materials from intestines, peritoneal cavity, uterine cavity and endometrial tissues, v) standardization of the nested-PCR method on bacterial DNA isolates from the tested biological materials, vi) submission of samples for sequencing. | Diagnostic test | Endometriosis, Idiopathic infertility |
Primary outcome
Composition of intestinal, peritoneal and uterine microbiome in both study arms
Time frame: up to 6 months
Percentage composition of the local bacterial population by phyla and genera
4 secondary outcomes
Relation of the composition of intestinal, peritoneal and uterine microbiome and endometriosis stage
Time frame: up to 6 months
Relation of the uterine microbiome to the intestinal and peritoneal microbiome in women with endometriosis and idiopathic infertility
Time frame: up to 6 moths
Relation of intestinal, peritoneal and uterine microbiome and symptoms
Time frame: up to 6 moths
Composition of intestinal, peritoneal and uterineand quality of life
Time frame: up to 6 moths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Robert Jach, Prof. Ph.D. study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Next Generation Sequencing (NGS) in people with Endometriosis and Infertility Unexplained, run by Jagiellonian University at 1 site in Poland.
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 4 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: looking for participants now, as of the sponsor's last update on 15 Apr 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iwona M. Gawron, Ph.D. (+48 124248571, iwona.gawron@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of intestinal, peritoneal and uterine microbiome in both study arms (time frame: up to 6 months). 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 15 Apr 2025.