Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy

Endometriosis Ovary Clinical Trial

Official title:

Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826355
• Other study ID #: OR
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 2018

Study information

• Verified date: January 2019
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endometriosis is a disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis, which can coexist in the same patient, exist: deep infiltrating endometriosis (implants infiltrate > 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA). OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured during resection. Consequently, ovarian reserve decreases, worsening the reproductive prognosis of patients affected. The main objective of the present study is to compare laser versus conventional OMA excision according to ovarian reserve in a pairwise-data study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 45.

• Bilateral endometriomas.

• Endometrioma size > 3 cm.

• Pain and/or infertility as indication to surgical treatment.

Exclusion Criteria:

• History of cancer.

• Suspected malignancy.

• Evidence of premature ovarian failure.

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis Ovary

Intervention

Procedure:
• CO2 (carbon dioxide) laser vaporisation
CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma
• Stripping technique
Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian reserve	Antral follicular count by ultrasound: number of antral follicles.	7 months
Primary	Ovarian volume	Ovarian volume will be assesses by ultrasound, units given with milliliters	7 months
Secondary	Pregnancy rate	Pregnancy rate will be recorded during the 6 months follow-up	6 months after surgery