NCT06421857

Brief Summary

laparoscopic excision of ovarian endometriotic cysts is generally recommended because it has been associated with a higher spontaneous conception rate, residual ovarian function after the procedure may be affected

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

September 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

May 15, 2024

Last Update Submit

May 15, 2024

Conditions

Endometrioma

Outcome Measures

Primary Outcomes (1)

  • ovarian reserve

    measuring AMH level

    6 weeks after procedure

Study Arms (2)

suturing

ACTIVE COMPARATOR

after ovarian cystectomy for endometrioma, separate sutures were applied if there was significant bleeding

Procedure: suturing

bipolar electrocoagulation

ACTIVE COMPARATOR

after ovarian cystectomy for endometrioma, the inner wall was coagulated using bipolar electrocoagulation if there was significant bleeding

Procedure: bipolar electrocoagulation

Interventions

suturingPROCEDURE

laparoscopic cystectomy for endometrioma and hemostasis was done using suturing

suturing
bipolar electrocoagulationPROCEDURE

laparoscopic cystectomy for endometrioma and hemostasis was done bipolar electrocoagulation

bipolar electrocoagulation

Eligibility Criteria

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

You may qualify if:

  • to 35 years
  • unilateral endometriotic cyst

You may not qualify if:

  • anovulatory women women with decreased ovarian reserve women receiving hormonal treatment three months prior to surgery women with any contraindication to laparoscopy women with previous ovarian surgery possible ovarian malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Sutures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Osama Kamel, MD

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
postgraduate student

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 20, 2024

Study Start

September 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)