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CompletedNCT03826355Updated Feb 1, 2019

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

An interventional study of CO2 (carbon dioxide) laser vaporisation and Stripping technique in Endometriosis Ovary, sponsored by Hospital Clinic of Barcelona. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jan 2017, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

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Conditions studied

  • Endometriosis Ovary

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03

In context

Endometriosis

902 studies on the registry are indexed under Endometriosis; 260 are open to participants now.

This study's enrollment of 16 is below the median of 64 across 525 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 18 and 45.
  • Bilateral endometriomas.
  • Endometrioma size > 3 cm.
  • Pain and/or infertility as indication to surgical treatment.

Exclusion criteria

Exclusion Criteria:

  • History of cancer.
  • Suspected malignancy.
  • Evidence of premature ovarian failure.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    Stripping technique

    The endometrioma is removed according to standard surgery.

    Procedure: Stripping technique

  • 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

Interventions

  • ProcedureCO2 (carbon dioxide) laser vaporisation

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

  • ProcedureStripping technique

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

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What researchers measure

Primary outcomes

  1. Ovarian reserve

    Antral follicular count by ultrasound: number of antral follicles.

    Time frame: 7 months

  2. Ovarian volume

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

    Time frame: 7 months

Secondary outcomes

  1. Pregnancy rate

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

    Time frame: 6 months after surgery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03826355
Lead sponsor
Hospital Clinic of Barcelona
Responsible party
Francisco Carmona (Head of Gynecology, Hospital Clinic of Barcelona) — Principal investigator
First posted
Feb 1, 2019
Start date
Jan 2017
Primary completion
Dec 2017
Completion
May 2018
Last update
Feb 1, 2019

Study contacts

Francisco Carmona, MD PhD
principal investigator · Hospital Clinic of Barcelona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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