Fertility Limiting Diseases of Pelvic Organs and Their Influence on Receptivity of Endometrial Cavity: Prospective Clinical Trial

NCT06991595 | Recruiting

• 1 other identifier: NU 23-06-00327
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Adenomyosis; Fibroid Uterus; Endometriosis

Keywords

adenomyosis; cytoreductive resection; myomectomy; endometriosis; endometrial receptivity

Outcome Measures

Primary Outcomes (1)

• loss of endometrial receptivity

  frequency of patients with loss of receptivity

  12 weeks

Secondary Outcomes (1)

• pregnancy rate

  2 years

Study Arms (5)

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.

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.

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.

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.

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.

Procedure: cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis; Procedure: hysteroscopy

Interventions

cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis PROCEDURE

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.

adenomyosis; controls; deep infiltrating endometriosis; minimal or mild endometriosis; uterine fibroid

hysteroscopy PROCEDURE

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.

adenomyosis; controls; deep infiltrating endometriosis; minimal or mild endometriosis; uterine fibroid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 18-45 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

General Hospital in Prague

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Adenomyosis; Leiomyoma; Endometriosis

Interventions

Uterine Myomectomy; Hysteroscopy

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Obstetric Surgical Procedures

Study Officials

• Michal Mara

  General Hospital in Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristyna Hlinecka, MD, PhD

CONTACT

00420605413210; Kristyna.Hlinecka2@vfn.cz

Michal Mara, MD,PhD,Prof.

CONTACT

224967001; myom@seznam.cz

Study Design

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

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: May 28, 2025
• Study Start: April 1, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CZ (1)