The Ovarian Reserve and Laparoscopic Ovarian Drilling | NCT03326024

Studies
The Ovarian Reserve and Laparoscopic Ovarian Drilling

NCT03326024

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Oct 30, 2017Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Polycystic Ovary Syndrome

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Estimated

Primary Completion Date

Oct 1, 2018Estimated

Completion Date

Oct 1, 2018Estimated

First Submitted Date

Oct 20, 2017

First Submission Date that Met QC Criteria

Oct 27, 2017

First Posted Date

Oct 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2017

Last Update Posted Date

Oct 30, 2017Actual

Description Module

Brief Summary

Long term assessment of ovarian reserve after more than two years of laparoscopic ovarian drilling in Polycystic Ovary Syndrome

Detailed Description

Inclusion criteria:

Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.

Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling

Anti-mullerian hormone (as an indicator for ovarian reserve) will be measured for the two groups and data collected will be compared

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Patients with Polycystic Ovary Syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.
B		Patients with Polycystic Ovary Syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of anti-mullerian hormone after laparoscopic ovarian drilling		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.

Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling

Exclusion Criteria:

Age <19 or > 35 years.
BMI <19 or > 35
patients refusing to participate in the study.
previous ovarian cystectomy.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

OUPATIENT CLINICS OF women health hospital - Assiut university

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

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Browse Branches

Not provided