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

Status: Recruiting
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

Contact Information
Primary
Kristyna Hlinecka, MD, PhD
Kristyna.Hlinecka2@vfn.cz
00420605413210
Backup
Michal Mara, MD,PhD,Prof.
myom@seznam.cz
224967001
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 236
Treatments
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.
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.
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.
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.
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.
Sponsors
Leads: Charles University, Czech Republic

This content was sourced from clinicaltrials.gov