Skip to main content
OpenTrials
Completed

NCT Number: NCT06106932

GnRH-a on Angiogenesis of Endometriosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Angiogenesis Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

32 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Patras University School of Medicine, Patra, Peloponnese, Greece

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leuprolide Acetate

Drug

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

Primary outcomes

  1. VEGF

    Time frame: 3 months

    VEGF levels with or without leuprolide acetate treatment

  2. Tissue factor

    Time frame: 3 months

    Tissue factor levels with or without leuprolide acetate treatment

  3. PAR-2

    Time frame: 3 months

    PAR-2 levels with or without leuprolide acetate treatment

  4. SP1

    Time frame: 3 months

    SP1 levels with or without leuprolide acetate treatment

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

The Effects of GnRH-a on Angiogenesis of Endometriosis

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2023
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.