Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

NCT03615352 | Completed

• 1 other identifier: Laparoscopy in endometrioma
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Endometrioma

Keywords

Endometrioma; laparoscopy; ovarian reserve; pelvic pain

Outcome Measures

Primary Outcomes (1)

• Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .

  Evaluation 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.

  3 months after laparoscopy

Secondary Outcomes (2)

• 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 laparoscopy

• Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain.

  3 months after laparoscopy

Study Arms (2)

ovarian cystectomy

EXPERIMENTAL

laparoscopic ovarian cystectomy in endometrioma

Procedure: ovarian cystectomy

ovarian cyst aspiration and coagulation

EXPERIMENTAL

laparoscopic ovarian endometrioma aspiration and coagulation

Procedure: ovarian cyst aspiration and coagulation

Interventions

ovarian cystectomy PROCEDURE

laparoscopic ovarian cystectomy in endometrioma

ovarian cystectomy

ovarian cyst aspiration and coagulation PROCEDURE

laparoscopic ovarian cyst aspiration and coagulation in endometrioma

ovarian cyst aspiration and coagulation

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shaimaa Mostafa Mohammed Refaay El shemy: lead

Study Sites (1)

Cairo University

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Interventions

Blood Coagulation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Mohammed Zayed Abd Elaziz, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of Obstetrics and Gynecology, Kasr Al ainy Hospital

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: August 3, 2018
• Study Start: January 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

EG (1)