NCT01808170

Brief Summary

The purpose of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus laparoscopic cyst deroofing on ovarian reserve measured by serum levels of anti mullerian hormone and antral follicle count in patients with endometriomas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.4 years

First QC Date

March 6, 2013

Last Update Submit

March 25, 2015

Conditions

Endometrioma

Keywords

LaparoscopyAMHAFCEndometriomaovarian reserveOvarian cystectomyovarian cyst deroofing

Outcome Measures

Primary Outcomes (1)

  • comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by alteration of AMH level in endometrioma patients.

    17 months

Secondary Outcomes (2)

  • comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by antral follicle count estimation in endometrioma patients.

    17 months

  • comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by ovarian volume estimation in endometrioma patients.

    17 months

Study Arms (2)

laparoscopic ovarian cystectomy

ACTIVE COMPARATOR

laparoscopic ovarian cystectomy will be performed on proliferative phase of menstrual cycle.Anti-mullerian hormone level measurement and estimation of antral follicle count will be done before surgery and will be repeated one month after surgery.

Procedure: Laparoscopic ovarian cystectomy

laparoscopic cyst deroofing

ACTIVE COMPARATOR

laparoscopic cyst deroofing will be performed on proliferative phase of menstrual cycle.Anti-mullerian hormone level measurement and estimation of antral follicle count will be done before surgery and will be repeated one month after surgery.

Procedure: laparoscopic cyst deroofing

Interventions

Laparoscopic ovarian cystectomyPROCEDURE

will be performed using video control under general anesthesia, pneumoperitoneum is induced by carbon dioxide, with three 5-mm trocars in the lower abdomen and a 10-mm intraumbilical main trocar, and we will use 5-mm scissors and graspers, and Ringer's lactate solution for irrigation. Before initiating ovarian surgery, the ovaries are completely freed with obtuse and sharp dissection.after a cleavage plane between the cyst wall and ovarian cortex is identified, the ovaries are pulled slowly and gently in opposite directions by means of two a traumatic grasping forceps. After removing the pseudo capsule from the abdominal cavity, selective minimal (15 watt) bipolar coagulation of bleeding is performed, without excessive coagulation of the surgical defect to avoid damaging the ovary.

laparoscopic ovarian cystectomy
laparoscopic cyst deroofingPROCEDURE

will be performed using video control under general anesthesia, pneumoperitoneum is induced by CO2, with three 5-mm trocars in the lower abdomen and a 10-mm intraumbilical main trocar, and we will use 5-mm scissors and graspers, and Ringer's lactate solution for irrigation. Before initiating ovarian surgery, the ovaries are completely freed with obtuse and sharp dissection. after mobilizing the ovary, the contents of the cyst is removed with the suction-irrigator probe and the cavity is irrigated. The inside of the cyst is evaluated and the portion of ovarian cortex involved with endometriosis is removed. Small blood vessels from the ovarian bed and bleeding from the ovarian hilum can be controlled with bipolar electro coagulation (15 watt). Low-power bipolar coagulation applied to the inside wall of the redundant ovarian capsule

laparoscopic cyst deroofing

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 18-35 year
  • Regular menstrual cycles.
  • Endometrioma (unilateral or bilateral) diagnosed by transvaginal ultrasound with diameter ≥ 3 cm.

You may not qualify if:

  • Any previous ovarian surgery.
  • Evidence of polycystic ovary syndrome according to Rotterdam criteria
  • Two of three of:
  • Oligo- or chronic anovulation.
  • Clinical and/or biochemical signs of hyperandrogenism.
  • Polycystic ovaries.
  • Evidence of premature ovarian failure diagnosed by follicle stimulating hormone level ≥40 IU/L
  • Any endocrinal disease affecting ovarian function e.g. thyroid dysfunction, hyperprolactinemia.
  • Previous hormonal medications e.g. oral contraceptive pills, gonadotropin-releasing hormone analogue within the last 3 months before surgery.
  • Any suspicious findings of ovarian malignant diseases diagnosed by transvaginal ultrasound.
  • Contraindication to surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

Related Publications (1)

  • Sweed MS, Makled AK, El-Sayed MA, Shawky ME, Abd-Elhady HA, Mansour AM, Mohamed RM, Hemeda H, Nasr-Eldin EA, Attia NS, Eltaieb E, Allam H, Hussein A. Ovarian Reserve Following Laparoscopic Ovarian Cystectomy vs Cyst Deroofing for Endometriomas. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):877-882. doi: 10.1016/j.jmig.2018.06.022. Epub 2018 Sep 5.

    PMID: 30193971DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ahmed K. Makled, M.D.

    Assistant professor of Obstetrics & Gynecology, faculty of medicine, AinShams University

    STUDY DIRECTOR

  • Mohamed S. Sweed, M.D.

    Lecturer Obstetics & Gynecolog, faculty of medicine, AinShams University

    PRINCIPAL INVESTIGATOR

  • Neveen S. Mehanna, M.B.B.CH.

    AinShams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mohamed S. Sweed lecturer of Obstetrics & Gynecology AinShams University.

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 11, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

EG(1)