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OpenTrials
Completed

NCT Number: NCT03826355

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

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.

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Key information

Conditions

Endometriosis Ovary

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CO2 (carbon dioxide) laser vaporisation

Procedure

CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma

Stripping technique

Procedure

Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue

Primary outcomes

  1. Ovarian reserve

    Time frame: 7 months

    Antral follicular count by ultrasound: number of antral follicles.

  2. Ovarian volume

    Time frame: 7 months

    Ovarian volume will be assesses by ultrasound, units given with milliliters

Secondary outcomes

  1. Pregnancy rate

    Time frame: 6 months after surgery

    Pregnancy rate will be recorded during the 6 months follow-up

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 1, 2019
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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