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

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ClinicalTrials.gov Identifier: NCT03826355
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Francisco Carmona, Hospital Clinic of Barcelona

Brief 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.

Condition or disease Intervention/treatment Phase
Endometriosis Ovary Procedure: CO2 (carbon dioxide) laser vaporisation Procedure: Stripping technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized prospective pairwise-data study. Patients with bilateral endometrioma with surgical indication will be selected. Ovarian reserve will be evaluated before and after surgery in both ovaries separately, using antral follicle count (AFC) and volume measurement. Type of surgery in each ovary will be randomized in the operating room (standard cystectomy vs laser vaporisation). A blinded ultrasonographer will evaluate AFC and volume measurement in both ovaries, before and three and six months after surgery. Therefore, each ovary will be compared with its contralateral in the same patient.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The ultrasonographer will be blinded to the procedure performed in each ovary after surgery. The patient will not be told which procedure has been performed in each ovary. The investigator will not know which procedure has been performed in each ovary until the end of the study. Only the surgeon will know which procedure is performed in each ovary.
Primary Purpose: Treatment
Official Title: Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Active Comparator: Stripping technique
The endometrioma is removed according to standard surgery.
Procedure: Stripping technique
Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue

Experimental: Laser technique
The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser
Procedure: CO2 (carbon dioxide) laser vaporisation
CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma




Primary Outcome Measures :
  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 Outcome Measures :
  1. Pregnancy rate [ Time Frame: 6 months after surgery ]
    Pregnancy rate will be recorded during the 6 months follow-up



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826355


Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Francisco Carmona, MD PhD Hospital Clínic de Barcelona
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Responsible Party: Francisco Carmona, Head of Gynecology, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03826355    
Other Study ID Numbers: OR
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female