Impact on Ovarian Reserve According to the Type of Ovaria... | NCT03826355

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

NCT03826355

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Feb 1, 2019Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Endometriosis Ovary

Interventions

CO2 (carbon dioxide) laser vaporisation
Stripping technique

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Dec 2017Actual

Completion Date

May 2018Actual

First Submitted Date

Jan 20, 2019

First Submission Date that Met QC Criteria

Jan 30, 2019

First Posted Date

Feb 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2019

Last Update Posted Date

Feb 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stripping technique	Active Comparator	The endometrioma is removed according to standard surgery.	Procedure: Stripping technique
Laser technique	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
CO2 (carbon dioxide) laser vaporisation	Procedure	CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma	Laser technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ovarian reserve	Antral follicular count by ultrasound: number of antral follicles.	7 months
Ovarian volume	Ovarian volume will be assesses by ultrasound, units given with milliliters	7 months

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy rate	Pregnancy rate will be recorded during the 6 months follow-up	6 months after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francisco Carmona, MD PhD	Hospital Clinic of Barcelona	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002245	Carbon Dioxide

Ancestor Terms

ID	Term
D017554	Carbon Compounds, Inorganic
D007287	Inorganic Chemicals
D005740	Gases
D010087	Oxides

Browse Leaves

Not provided

Browse Branches

Not provided

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 Info

Masking

Triple

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.

Who Masked

ParticipantCare ProviderInvestigator