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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorCharles University, Czech Republic

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • cytoreductive resection of adenomyosis, myomectomy, resection of endometriosis

    Procedure/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.

  • hysteroscopy

    Procedure/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.

Treatment groups

236 Participants
are divided into 5 treatment groups
Group A: adenomyosis2 interventions
Group B: uterine fibroid2 interventions
Group C: deep infiltrating endometriosis2 interventions
Group D: minimal or mild endometriosis2 interventions
Group E: controls2 interventions

Trial outcomes

Primary outcomes

1

loss of endometrial receptivity

frequency of patients with loss of receptivity

Time frame
12 weeks

Secondary outcomes

1

pregnancy rate

the percentage of all attempts that leads to pregnancy

Time frame
2 years

Other outcomes

Sponsors and contacts

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