Endometriosis Ovary
Conditions
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.
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
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
* History of cancer. * Suspected malignancy. * Evidence of premature ovarian failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovarian reserve | 7 months | Antral follicular count by ultrasound: number of antral follicles. |
| Ovarian volume | 7 months | Ovarian volume will be assesses by ultrasound, units given with milliliters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | 6 months after surgery | Pregnancy rate will be recorded during the 6 months follow-up |
Outcome results
None listed