Clinical trial NCT06106932: GnRH-a on Angiogenesis of Endometriosis
Official title: The Effects of GnRH-a on Angiogenesis of Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angiogenesis
Endometriosis
Keywords: Endometriosis
Angiogenesis
GnRH-a
VEGF
SP1
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 32
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a prospective randomized follow up study with analysis of ovarian samples derived from GnRH agonists-treated and non-treated women before surgery. The randomization was performed by accessing a central internet-based randomization program. The random allocation sequence and the assignment of the participants to interventions were made by 2 of the authors \[A.K. and S.K\].
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose: Neo-angiogenesis is necessary for adhesion and invasiveness of endometriotic lesions in women affected by endometriosis. VEGF is one of the major components of angiogenesis and is part of the major pathway TF-PAR-2-VEGF that leads to neo-angiogenesis. SP1 is a transcriptional factor that has lately been studied for its crucial role in angiogenesis, via a distinct pathway. We hypothesize that by blocking angiogenetic pathways we can repress endometriotic lesions. GnRH-agonists are routinely used, especially pre-operatively, in endometriosis. It would be interesting to clarify which angiogenetic pathways are affected and pave the way for further research over anti-angiogenetic effects on endometriosis.

Methods: We used qRT-PCR to study mRNA expression levels of TF, PAR-2, VEGF and SP1 in endometriotic tissues of women who underwent surgery for endometriosis and received GnRH-a \[leuprolide acetate\] preoperatively.

Detailed description: The subjects in this study were women of reproductive age. From September 2015 to December 2022, sixty women with known endometriosis \[stage 2 and 3\], were recruited. Their mean age was 38 years. They were nulliparous and had a mean BMI of 27 kg/m2. The ovarian endometrioma, present in all the participants, was diagnosed by ultrasonography and/or magnetic resonance imaging.

This was a prospective randomized follow up study with analysis of ovarian samples derived from GnRH agonists-treated and non-treated women before surgery. The randomization was performed by accessing a central internet-based randomization program. The random allocation sequence and the assignment of the participants to interventions were made by 2 of the authors \[A.K. and S.K\].

After enrollment, patients were divided into 2 groups . During laparoscopy, biopsy specimens of the ovarian endometrioma were collected. The staging of endometriosis was based on the rASRM classification system. In group B, surgery was performed during the proliferative phase of the menstrual cycle. All biopsy specimens were collected in accordance with the guidelines of the Declaration of Helsinki and with the approval of the ethical committee of the General University Hospital of Patras. Informed consent was obtained from all women.

Eligibility criteria: Inclusion Criteria:

* reproductive age.
* endometriosis \[stage 2 and 3\]
* nulliparous

Exclusion Criteria:

* women who received any hormonal treatment within the 12 months before the surgical procedure
* obesity BMI\>32kg/m2

Primary outcomes:
measure: VEGF
timeFrame: 3 months
measure: Tissue factor
timeFrame: 3 months
measure: PAR-2
timeFrame: 3 months
measure: SP1
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Patra
country: Greece
facility: Patras University School of Medicine
state: Peloponnese
city: Yonago
country: Japan
facility: Tottori University Faculty of Medicine
state: Tottori-Ken
Study officials:
References: