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Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

Impact of Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation on Ovarian Reserve and Pelvic Pain in Cases of Ovarian Endometrioma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03615352
Enrollment
92
Registered
2018-08-03
Start date
2018-01-01
Completion date
2018-10-01
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Endometrioma

Keywords

Endometrioma, laparoscopy, ovarian reserve, pelvic pain

Brief summary

The aim of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on ovarian reserve and pelvic pain in cases of ovarian endometrioma.

Detailed description

All patients are presenting with ovarian endometrioma. They are all subjected to informed written consent, full history, general examination, local examination and transvaginal ultrasound. Follicular stimulating hormone (FSH), Lutenizing hormone (LH), Anti Mullerian hormone (AMH), Antral follicular count (AFC) and chronic pelvic pain which is assessed by Visual Analogue Scale (VAS) of pain scoring system ,all are to be determined before and after laparoscopic surgery (postoperative three months); for two groups (Group A) cystectomy and (Group B) aspiration and coagulation. Histopathological examination was done to the cystectomy group to confirm endometriosis and detect the presence of healthy ovarian tissue in the excised cyst wall.

Interventions

laparoscopic ovarian cystectomy in endometrioma

PROCEDUREovarian cyst aspiration and coagulation

laparoscopic ovarian cyst aspiration and coagulation in endometrioma

Sponsors

Shaimaa Mostafa Mohammed Refaay El shemy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Female with age group 20-40 years. * Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥3cm.

Exclusion criteria

* Previous ovarian surgery. * Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus, hypothyroidism. * Polycystic ovary syndrome (PCO). * Suspicion of ovarian malignancy by ultrasound. * Other pelvic pathology e.g. uterine fibroid, pelvic inflammatory disease (PID). * High basal FSH \>10mIU/mL (milli-international unit per milliliter).

Design outcomes

Primary

MeasureTime frameDescription
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .3 months after laparoscopyEvaluation of ovarian reserve which is measured by Anti Mullerian hormone (AMH) in nano-gram per milliliter (ng/ml) before laparoscopy and after the surgery by 3 months.

Secondary

MeasureTime frameDescription
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve.3 months after laparoscopyEvaluation of ovarian reserve by assessment of Antral Follicular Count (AFC) by measuring the number of visible ovarian follicles (2-10 mm mean diameter) that are observed during transvaginal ultrasonography in the early follicular phase (cycle days 2-5) in both ovaries. It is done before laparoscopy and after the surgery by 3 months.
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain.3 months after laparoscopyPelvic pain is measured by Visual analogue scale of pain (VAS) which is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10-cm scale). The pelvic pain is assessed before laparoscopy and after laparoscopy by 3 months.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026