Skip to main content
OpenTrials
Completed

NCT Number: NCT03615352

Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Endometrioma Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ovarian cystectomy

Procedure

laparoscopic ovarian cystectomy in endometrioma

ovarian cyst aspiration and coagulation

Procedure

laparoscopic ovarian cyst aspiration and coagulation in endometrioma

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 .

    Time frame: 3 months after laparoscopy

    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.

Secondary outcomes

  1. Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve.

    Time frame: 3 months after laparoscopy

    Evaluation 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.

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

    Time frame: 3 months after laparoscopy

    Pelvic 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.

Sponsors and collaborators

Lead sponsor

Shaimaa Mostafa Mohammed Refaay El shemy

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2018
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.