AdenomyosisREAdMENCT06991595
Fertility Limiting Diseases of Pelvic Organs and Their Influence on Receptivity of Endometrial Cavity: Prospective Clinical Trial
An observational study of Adenomyosis and Fibroid Uterus, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
In this project, we will characterize the effects of fertility limiting diseases of pelvic organs on the receptivity of the endometrium. The primary aim of the project is the characterization of endometrium in patients with infertility suffering from AD, UF and DE, and compare it with infertile patients with minimal… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenomyosis, Fibroid Uterus, Endometriosis
- What is being tested?
- cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis and hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 236 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2023to 31 Dec 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: * confirmed adenomyosis, score 3 or 4 [24] * planned conception using IVFwomen with at least 1 year infertility * confirmed uterine myoma/s with largest diameter from 25 to 55 mm and no interaction with uterine cavity (on US and hysteroscopy), i.e. types 3, 4, 5 or 6 [25] * presence of typical US features of leiomyomas [24] * planned conception using IVF women with typical symptoms of DE * confirmed DE (expert ultrasound and/or MRI) patients with confirmed endometriosis of stage I-II based on r-AFS [26] * planned conception patients without diseases mentioned above and with male factor of infertility * planned conception
Who may be able to join
- agreement with participation in the study
- age between 18 - 45 years (at the start of patient´s participation in the study)women with at least 1 year infertility
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
General Hospital in Prague
Prague
Michal Mara, MD,PhD,Prof., 224967001, Michal.Mara@vfn.cz
About this study
Official title: Fertility Limiting Diseases of Pelvic Organs and Their Influence on Receptivity of Endometrial Cavity: Prospective Clinical Trial (REAdME)
In this project, we will characterize the effects of fertility limiting diseases of pelvic organs on the receptivity of the endometrium. The primary aim of the project is the characterization of endometrium in patients with infertility suffering from AD, UF and DE, and compare it with infertile patients with minimal or mild endometriosis but no AD or UF (ETRS group), and with healthy women with only male factor of infertility (CTRL group, controls). The proper infertility treatment of patients with AD,UF and endometriosis is controversial and lacking clear evidence based algorithms. Despite their topical character, especially AD and DE (and UFs as well if present as multiple lesions) can be classified as systemic diseases in relation to women´s fertility. The presumed impact of these pathologies to endometrial receptivity (no matter they do not occur in the uterine cavity itself) can beseen as a fascinating hypothesis. Eradication of these diseases could have a potential to increase the prognosis of these women fundamentally.
Read the detailed description
The project will be studied in two parts - laboratory and clinical. In the laboratory part, the parameters of endometrial receptivity will be specified in women with UF, AD, DE, minimal and mild endometriosis and in healthy controls. These parameters will be also compared in surgically treated patients before and after the procedures. This data will also be compared with patients from both control groups (ETRS, CTRL). First, we will perform bulk RNA Sequencing (RNA-Seq), to characterize the main differences in RNA expression of the endometrium between women with successful and unsuccessful conceptions. The candidate genes will be used for choosing the RTqPCR controlled set of samples for single-nucleus RNA-Seq (snRNA-Seq) profiling of the endometrial tissue. The results will be validated using RT-qPCR. In the clinical part, we will analyse the reproductive results of surgical and conservative management of infertility associated with AD and UF. Collectively, our data will provide information for the development of new diagnostic tools for better investigation and choice of treatment for patients with infertility. This project is not a clinical trial.
- Conditions
- Adenomyosis, Fibroid Uterus, Endometriosis
- Being tested
- cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis, hysteroscopy
- Keywords
- adenomyosis, cytoreductive resection, myomectomy, endometriosis, endometrial receptivity
- Medical subject headings
- Adenomyosis, Leiomyoma, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytoreductive resection of adenomyosis, myomectomy, resection of endometriosisProcedure or surgery
All women chosen for the study will be divided into the groups (AD, UF, DE, ETRS, CTRL) based on the inclusion/exclusion criteria (Table 2).A meticulous concern will be dedicated to patients´ education on advantages and disadvantages (including the eventual risks) of surgical and conservative management of AD and UF. These patients will be allocated into surgical or conservative arm of the study based on their inclinations: either to fertility saving surgical procedure (FSS) with subsequent IVF, or directly to IVF. This phenomenon of the importance of patients´ preferences in controversial clinical situations is the usual part of the management of infertile patients with AD or UF.
hysteroscopyProcedure or surgery
Sampling of endometrium (Hysteroscopy) The samples will be collected using hysteroscopy, scheduled into the secretory phase of endometrial cycle. During hysteroscopy, the uterine cavity will be observed and described in the surgical protocol (capacity, symmetry, presence of intrauterine pathologies, internal ostia of the tubes). The 3.2 mm wide hysteroscope will be used. Its usage usually does not require any anaesthesia. The endometrium will be taken using biopsy forceps (7 French / 2.3 mm) and immediately frozen on dry ice and stored at -80 °C until processing. Two pieces of endometrium per patient will be collected - one for isolation of RNA and bulk RNA-Seq and/or RT-qPCR and the second one for isolation of nuclei and snRNA-Seq or validation using snRT-qPCR. If some unexpected findings would be observed during hysteroscopy (especially some interfering with fertility), they would be hysteroscopically removed and endometrial sampling postponed.
| Study group | Role | What they receive |
|---|---|---|
| adenomyosis | This project is divided into two parts - laboratory and clinical. This study utilizes a prospective, controlled, non-randomized design. In this study 5 main groups of infertile patients will be studied:women with severe adenomyosis (AD), uterine fibroids (UF), deep infiltrating endometriosis (DE),minimal or mild endometriosis (ETRS) and controls with only male factor of infertility and no signs ofpreviously mentioned diseases (CTRL). The patients will be recruited, and samples collected during the first 3 years of the project. Receives: Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis; Procedure: hysteroscopy | |
| uterine fibroid | This project is divided into two parts - laboratory and clinical. This study utilizes a prospective, controlled, non-randomized design. In this study 5 main groups of infertile patients will be studied:women with severe adenomyosis (AD), uterine fibroids (UF), deep infiltrating endometriosis (DE),minimal or mild endometriosis (ETRS) and controls with only male factor of infertility and no signs ofpreviously mentioned diseases (CTRL). The patients will be recruited, and samples collected during the first 3 years of the project. Receives: Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis; Procedure: hysteroscopy | |
| deep infiltrating endometriosis | This project is divided into two parts - laboratory and clinical. This study utilizes a prospective, controlled, non-randomized design. In this study 5 main groups of infertile patients will be studied:women with severe adenomyosis (AD), uterine fibroids (UF), deep infiltrating endometriosis (DE),minimal or mild endometriosis (ETRS) and controls with only male factor of infertility and no signs ofpreviously mentioned diseases (CTRL). The patients will be recruited, and samples collected during the first 3 years of the project. Receives: Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis; Procedure: hysteroscopy | |
| minimal or mild endometriosis | This project is divided into two parts - laboratory and clinical. This study utilizes a prospective, controlled, non-randomized design. In this study 5 main groups of infertile patients will be studied:women with severe adenomyosis (AD), uterine fibroids (UF), deep infiltrating endometriosis (DE),minimal or mild endometriosis (ETRS) and controls with only male factor of infertility and no signs ofpreviously mentioned diseases (CTRL). The patients will be recruited, and samples collected during the first 3 years of the project. Receives: Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis; Procedure: hysteroscopy | |
| controls | This project is divided into two parts - laboratory and clinical. This study utilizes a prospective, controlled, non-randomized design. In this study 5 main groups of infertile patients will be studied:women with severe adenomyosis (AD), uterine fibroids (UF), deep infiltrating endometriosis (DE),minimal or mild endometriosis (ETRS) and controls with only male factor of infertility and no signs ofpreviously mentioned diseases (CTRL). The patients will be recruited, and samples collected during the first 3 years of the project. Receives: Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis; Procedure: hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
loss of endometrial receptivity
frequency of patients with loss of receptivity
Measured: 12 weeks
Secondary outcomes (1)
pregnancy rate
the percentage of all attempts that leads to pregnancy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Apr 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Prospective
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Mara, Principal investigator, General Hospital in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991595
- Sponsor's protocol ID
- NU 23-06-00327
- Acronym
- REAdME
- Status last verified
- May 2025
- First submitted
- 3 Dec 2023
- Last updated
- 28 May 2025
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Limiting Diseases of Pelvic Organs and Their Influence on Receptivity of Endometrial Cavity: Prospective Clinical Trial (REAdME)
- ClinicalTrials.gov ID
- NCT06991595
- Acronym / sponsor ID
- REAdME / NU 23-06-00327
- Conditions
- Adenomyosis, Fibroid Uterus, Endometriosis
- Keywords
- adenomyosis, cytoreductive resection, myomectomy, endometriosis, endometrial receptivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 May 2025 (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.
In this project, we will characterize the effects of fertility limiting diseases of pelvic organs on the receptivity of the endometrium. The primary aim of the project is the characterization of endometrium in patients with infertility suffering from AD, UF and DE, and compare it with infertile patients with minimal or mild endometriosis but no AD or UF (ETRS group), and with healthy women with only male factor of infertility (CTRL group, controls). The proper infertility treatment of patients with AD,UF and endometriosis is controversial and lacking clear evidence based algorithms. Despite their topical character, especially AD and DE (and UFs as well if present as multiple lesions) can be classified as systemic diseases in relation to women´s fertility. The presumed impact of these pathologies to endometrial receptivity (no matter they do not occur in the uterine cavity itself) can beseen as a fascinating hypothesis. Eradication of these diseases could have a potential to increase the prognosis of these women fundamentally.
Detailed description
The project will be studied in two parts - laboratory and clinical. In the laboratory part, the parameters of endometrial receptivity will be specified in women with UF, AD, DE, minimal and mild endometriosis and in healthy controls. These parameters will be also compared in surgically treated patients before and after the procedures. This data will also be compared with patients from both control groups (ETRS, CTRL). First, we will perform bulk RNA Sequencing (RNA-Seq), to characterize the main differences in RNA expression of the endometrium between women with successful and unsuccessful conceptions. The candidate genes will be used for choosing the RTqPCR controlled set of samples for single-nucleus RNA-Seq (snRNA-Seq) profiling of the endometrial tissue. The results will be validated using RT-qPCR. In the clinical part, we will analyse the reproductive results of surgical and conservative management of infertility associated with AD and UF. Collectively, our data will provide information for the development of new diagnostic tools for better investigation and choice of treatment for patients with infertility. This project is not a clinical trial.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| adenomyosis | – | Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis, Procedure: hysteroscopyThis project is divided into two parts - laboratory and clinical. This study utilizes a prospective, controlled, non-randomized design. In this study 5 main groups of infertile patients will be studied:women with severe adenomyosis (AD), uterine fibroids (UF), deep infiltrating endometriosis (DE),minimal or mild endometriosis (ETRS) and controls with only male factor of infertility and no signs ofpreviously mentioned diseases (CTRL). The patients will be recruited, and samples collected during the first 3 years of the project. |
| uterine fibroid | – | Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis, Procedure: hysteroscopyThis project is divided into two parts - laboratory and clinical. This study utilizes a prospective, controlled, non-randomized design. In this study 5 main groups of infertile patients will be studied:women with severe adenomyosis (AD), uterine fibroids (UF), deep infiltrating endometriosis (DE),minimal or mild endometriosis (ETRS) and controls with only male factor of infertility and no signs ofpreviously mentioned diseases (CTRL). The patients will be recruited, and samples collected during the first 3 years of the project. |
| deep infiltrating endometriosis | – | Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis, Procedure: hysteroscopyThis project is divided into two parts - laboratory and clinical. This study utilizes a prospective, controlled, non-randomized design. In this study 5 main groups of infertile patients will be studied:women with severe adenomyosis (AD), uterine fibroids (UF), deep infiltrating endometriosis (DE),minimal or mild endometriosis (ETRS) and controls with only male factor of infertility and no signs ofpreviously mentioned diseases (CTRL). The patients will be recruited, and samples collected during the first 3 years of the project. |
| minimal or mild endometriosis | – | Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis, Procedure: hysteroscopyThis project is divided into two parts - laboratory and clinical. This study utilizes a prospective, controlled, non-randomized design. In this study 5 main groups of infertile patients will be studied:women with severe adenomyosis (AD), uterine fibroids (UF), deep infiltrating endometriosis (DE),minimal or mild endometriosis (ETRS) and controls with only male factor of infertility and no signs ofpreviously mentioned diseases (CTRL). The patients will be recruited, and samples collected during the first 3 years of the project. |
| controls | – | Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis, Procedure: hysteroscopyThis project is divided into two parts - laboratory and clinical. This study utilizes a prospective, controlled, non-randomized design. In this study 5 main groups of infertile patients will be studied:women with severe adenomyosis (AD), uterine fibroids (UF), deep infiltrating endometriosis (DE),minimal or mild endometriosis (ETRS) and controls with only male factor of infertility and no signs ofpreviously mentioned diseases (CTRL). The patients will be recruited, and samples collected during the first 3 years of the project. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * confirmed adenomyosis, score 3 or 4 [24] * planned conception using IVFwomen with at least 1 year infertility * confirmed uterine myoma/s with largest diameter from 25 to 55 mm and no interaction with uterine cavity (on US and hysteroscopy), i.e. types 3, 4, 5 or 6 [25] * presence of typical US features of leiomyomas [24] * planned conception using IVF women with typical symptoms of DE * confirmed DE (expert ultrasound and/or MRI) patients with confirmed endometriosis of stage I-II based on r-AFS [26] * planned conception patients without diseases mentioned above and with male factor of infertility * planned conception
Key inclusion criteria (2 listed)
- agreement with participation in the study
- age between 18 - 45 years (at the start of patient´s participation in the study)women with at least 1 year infertility
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| cytoreductive resection of adenomyosis, myomectomy, resection of endometriosisAll women chosen for the study will be divided into the groups (AD, UF, DE, ETRS, CTRL) based on the inclusion/exclusion criteria (Table 2).A meticulous concern will be dedicated to patients´ education on advantages and disadvantages (including the eventual risks) of surgical and conservative management of AD and UF. These patients will be allocated into surgical or conservative arm of the study based on their inclinations: either to fertility saving surgical procedure (FSS) with subsequent IVF, or directly to IVF. This phenomenon of the importance of patients´ preferences in controversial clinical situations is the usual part of the management of infertile patients with AD or UF. | Procedure or surgery | adenomyosis, controls, deep infiltrating endometriosis, minimal or mild endometriosis, uterine fibroid |
| hysteroscopySampling of endometrium (Hysteroscopy) The samples will be collected using hysteroscopy, scheduled into the secretory phase of endometrial cycle. During hysteroscopy, the uterine cavity will be observed and described in the surgical protocol (capacity, symmetry, presence of intrauterine pathologies, internal ostia of the tubes). The 3.2 mm wide hysteroscope will be used. Its usage usually does not require any anaesthesia. The endometrium will be taken using biopsy forceps (7 French / 2.3 mm) and immediately frozen on dry ice and stored at -80 °C until processing. Two pieces of endometrium per patient will be collected - one for isolation of RNA and bulk RNA-Seq and/or RT-qPCR and the second one for isolation of nuclei and snRNA-Seq or validation using snRT-qPCR. If some unexpected findings would be observed during hysteroscopy (especially some interfering with fertility), they would be hysteroscopically removed and endometrial sampling postponed. | Procedure or surgery | adenomyosis, controls, deep infiltrating endometriosis, minimal or mild endometriosis, uterine fibroid |
Primary outcome
loss of endometrial receptivity
Time frame: 12 weeks
frequency of patients with loss of receptivity
1 secondary outcome
pregnancy rate
Time frame: 2 years
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 28 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Michal Mara principal investigator
General Hospital in Prague
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 Adenomyosis and Fibroid Uterus, run by Charles University, Czech Republic at 1 site in Czechia.
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 1 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 28 May 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 Czechia. 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 Kristyna Hlinecka, MD, PhD (00420605413210, Kristyna.Hlinecka2@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
loss of endometrial receptivity (time frame: 12 weeks). 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 28 May 2025.