NCT02754648

Brief Summary

Is ovarian reserve and fecundity rate higher with laparoscopic ovarian aspiration rather than laparoscopic ovarian cystectomy and laparoscopic ovarian de-roofing in infertile woman with ovarian endometrioma or not?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

March 16, 2016

Last Update Submit

April 26, 2016

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • The antral follicular count which records the number of visible ovarian follicle (2-10 mm mean diameter) seen by transvaginal ultrasound on menstrual cycle( days 2_5)

    Cut point(3-10)

    One month

Secondary Outcomes (2)

  • Anti mullerian hormone level in blood secreted by antral follicles 2-6 mm diameter in ovary

    One month

  • Follicle stimulating hormone in blood secreted by antral follicles on day 2-4 of menstrual cycle

    One month

Study Arms (3)

Group A; laparoscopic ovarian endometrial aspiration

ACTIVE COMPARATOR

Laparoscopic ovarian endometrial aspiration will be done for thirty patients with ovarian endometriotic cyst. .

Procedure: laparoscopic ovarian endometriotic cyst

group B; laparoscopic ovarian endometrial stripping

ACTIVE COMPARATOR

Laparoscopic ovarian endometrial stripping will be done for thirty patients with ovarian endometriotic cyst.

Procedure: laparoscopic ovarian endometriotic cyst

Group c laparoscopic ovarian endometrial de-roofing

ACTIVE COMPARATOR

Laparoscopic ovarian endometrial de-roofing and bed cauterization will be done for thirty patients with ovarian endometriotic cyst.

Procedure: laparoscopic ovarian endometriotic cyst

Interventions

laparoscopic ovarian endometriotic cystPROCEDURE
Group A; laparoscopic ovarian endometrial aspirationGroup c laparoscopic ovarian endometrial de-roofinggroup B; laparoscopic ovarian endometrial stripping

Eligibility Criteria

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

You may qualify if:

  • Infertile woman aged 18-35 years old.
  • Endometriotic ovarian cyst with size less than or equal 5 cm.

You may not qualify if:

  • Other than included criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 16, 2016

First Posted

April 28, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 28, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share