GnRH-a on Angiogenesis of Endometriosis

Endometriosis Clinical Trial

Official title:

The Effects of GnRH-a on Angiogenesis of Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06106932
• Other study ID #: 11-05-2015/83
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: January 2023

Study information

• Verified date: October 2023
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 32 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Angiogenesis
• Endometriosis

Intervention

Drug:
• Leuprolide Acetate
Leuprolide acetate was administered 3 months before laparoscopy in women of group A.

Locations

Country	Name	City	State
Greece	Patras University School of Medicine	Patra	Peloponnese
Japan	Tottori University Faculty of Medicine	Yonago	Tottori-Ken

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Countries where clinical trial is conducted

Greece,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VEGF	VEGF levels with or without leuprolide acetate treatment	3 months
Primary	Tissue factor	Tissue factor levels with or without leuprolide acetate treatment	3 months
Primary	PAR-2	PAR-2 levels with or without leuprolide acetate treatment	3 months
Primary	SP1	SP1 levels with or without leuprolide acetate treatment	3 months