GnRH-a on Angiogenesis of Endometriosis

NCT ID: NCT06106932

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2023-01-31

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.

Conditions

Angiogenesis; Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Leuprolide Acetate

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Leuprolide Acetate

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 32 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Patras

OTHER

Sponsor Role: lead

Responsible Party

Apostolos Kaponis

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Patras University School of Medicine

Patra, Peloponnese, Greece

Tottori University Faculty of Medicine

Yonago, Tottori, Japan

Countries

Greece; Japan

References

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.

Reference Type: DERIVED

PMID: 38639888 (View on PubMed)

Other Identifiers

11-05-2015/83

Identifier Type: -

Identifier Source: org_study_id