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GnRH-a on Angiogenesis of Endometriosis

The Effects of GnRH-a on Angiogenesis of Endometriosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06106932
Enrollment
60
Registered
2023-10-30
Start date
2015-09-30
Completion date
2023-01-31
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angiogenesis, Endometriosis

Keywords

Endometriosis, Angiogenesis, GnRH-a, VEGF, SP1

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.

Interventions

DRUGLeuprolide Acetate

Leuprolide acetate was administered 3 months before laparoscopy in women of group A.

Sponsors

University of Patras
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

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 \[A.K. and S.K\].

Eligibility

Sex/Gender
FEMALE
Age
32 Years to 42 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
VEGF3 monthsVEGF levels with or without leuprolide acetate treatment
Tissue factor3 monthsTissue factor levels with or without leuprolide acetate treatment
PAR-23 monthsPAR-2 levels with or without leuprolide acetate treatment
SP13 monthsSP1 levels with or without leuprolide acetate treatment

Countries

Greece, Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026