GnRH-a on Angiogenesis of Endometriosis

Sponsor

University of Patras (Other)

Overall Status

Completed

CT.gov ID

NCT06106932

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Angiogenesis Endometriosis	Drug: Leuprolide Acetate	N/A

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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].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].

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

The Effects of GnRH-a on Angiogenesis of Endometriosis

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Jan 1, 2023

Actual Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: GnRH-a + 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 Leuprolide acetate was administered 3 months before laparoscopy in women of group A.
No Intervention: GnRH-a - 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.

Arm

Intervention/Treatment

Active Comparator: GnRH-a +

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

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

No Intervention: GnRH-a -

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.

Outcome Measures

Primary Outcome Measures

VEGF [3 months]
VEGF levels with or without leuprolide acetate treatment
Tissue factor [3 months]
Tissue factor levels with or without leuprolide acetate treatment
PAR-2 [3 months]
PAR-2 levels with or without leuprolide acetate treatment
SP1 [3 months]
SP1 levels with or without leuprolide acetate treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

32 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Patras University School of Medicine	Patra	Peloponnese	Greece	26504
2	Tottori University Faculty of Medicine	Yonago	Tottori-Ken	Japan	683-8503

Sponsors and Collaborators

University of Patras

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Apostolos Kaponis, Associate Professor, University of Patras

ClinicalTrials.gov Identifier:

NCT06106932

Other Study ID Numbers:

11-05-2015/83

First Posted:

Oct 30, 2023

Last Update Posted:

Oct 30, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Apostolos Kaponis, Associate Professor, University of Patras

Additional relevant MeSH terms:

Endometriosis

Leuprolide

Study Results

No Results Posted as of Oct 30, 2023