Clinical trial NCT06991595: Fertility Limiting Diseases of Pelvic Organs and Their Influence on Receptivity of Endometrial Cavity: Prospective Clinical Trial
Official title: Fertility Limiting Diseases of Pelvic Organs and Their Influence on Receptivity of Endometrial Cavity: Prospective Clinical Trial (REAdME)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenomyosis
Fibroid Uterus
Endometriosis
Keywords: adenomyosis
cytoreductive resection
myomectomy
endometriosis
endometrial receptivity
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

-

Primary outcomes:
measure: loss of endometrial receptivity
timeFrame: 12 weeks
Secondary outcomes:
measure: pregnancy rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: General Hospital in Prague
Study officials:
affiliation: General Hospital in Prague
name: Michal Mara
role: PRINCIPAL_INVESTIGATOR
References: