GnRH-a on Angiogenesis of Endometriosis

NCT06106932 | Completed DMC

• 1 other identifier: 11-05-2015/83
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Angiogenesis; Endometriosis

Keywords

Endometriosis; Angiogenesis; GnRH-a; VEGF; SP1

Outcome Measures

Primary Outcomes (4)

• VEGF

  VEGF levels with or without leuprolide acetate treatment

  3 months

• Tissue factor

  Tissue factor levels with or without leuprolide acetate treatment

  3 months

• PAR-2

  PAR-2 levels with or without leuprolide acetate treatment

  3 months

• SP1

  SP1 levels with or without leuprolide acetate treatment

  3 months

Study Arms (2)

GnRH-a +

ACTIVE COMPARATOR

Group A \[GnRHa+\] consisted of 30 women with a mean age of 35.5 years and a mean BMI of 27 kg/m2. Seventeen of them were stage 2 and 13 were stage 3 endometriosis. They received GnRH-a \[leuprolide acetate\] for a period of 3 months prior to surgery, whereas they had not received any hormonal treatment within the 12 months before the surgical procedure.

Drug: Leuprolide Acetate

GnRH-a -

NO INTERVENTION

Group B \[GnRHa-\] consisted of 30 patients with a mean age of 38 years and a mean BMI of 27 kg/m2. Sixteen of them had stage 2 and 14 had stage 3 endometriosis. They did not receive GnRH-a treatment before operation. In addition, no treatment with oral contraceptives or other therapy was administered within 12 months prior to surgery.

Interventions

Leuprolide Acetate DRUG

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

GnRH-a +

Eligibility Criteria

• Age: 32 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (2)

Patras University School of Medicine

Patra, Peloponnese, 26504, Greece

Location

Tottori University Faculty of Medicine

Yonago, Tottori, 683-8503, Japan

Location

Related Publications (1)

• Filindris T, Papakonstantinou E, Keramida M, Panteris E, Kalogeropoulos S, Georgopoulos N, Taniguchi F, Adonakis G, Harada T, Kaponis A. The effect of GnRH-a on the angiogenesis of endometriosis. Hormones (Athens). 2024 Sep;23(3):509-515. doi: 10.1007/s42000-024-00559-6. Epub 2024 Apr 19.

  PMID: 38639888 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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 \[A.K. and S.K\].

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: September 1, 2015
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); JP (1)