RecruitingNCT06991595

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

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

Sponsor

Charles University, Czech Republic

Enrollment

236 participants

Start Date

Apr 1, 2023

Study Type

OBSERVATIONAL

Conditions

Endometriosis Adenomyosis Fibroid Uterus

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria2

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 Criteria1

Interventions

PROCEDUREcytoreductive resection of adenomyosis, myomectomy, resection of endometriosis

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.

PROCEDUREhysteroscopy

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.