Serial Measurement of Serum Antimullerian Hormone in Wome... | NCT01065168

Studies
Serial Measurement of Serum Antimullerian Hormone in Women Undergoing Laparoscopic Cystectomy of Endometrioma

NCT01065168

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Feb 17, 2010Estimated

Enrollment

43Actual

Phase

Not provided

Conditions

Endometriosis

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

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2010Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Feb 6, 2010

First Submission Date that Met QC Criteria

Feb 8, 2010

First Posted Date

Feb 9, 2010Estimated

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

Feb 16, 2010

Last Update Posted Date

Feb 17, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this trial is to study ovarian reserve after laparoscopic endometrioma cystectomy by measuring antimullerian hormone. The measurements were measured before the surgery and one week and three months after the surgery.

Detailed Description

Antimullerian hormone will be obtained in patients with ovarian endometrioma before laparoscopic cystectomy is done. The measurements were compared with antimullerian hormone after one week and three months after the surgery. Forty three patients will be included in this study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

43Actual

Label	Type	Description	Intervention Names
endometrioma		ovarian endometrioma undergoing cystectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ovarian reserve before and after ovarian endometrioma cystectomy.		one week and three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20-40 years
ovarian endometrioma > or = 3 cms
laparoscopic cystectomy treatment

Exclusion Criteria:

previous ovarian surgery
other ovarian pathology
previous drugs or hormonal treatment for endometrioma

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

ovarian endometrioma performed laparoscopic cystectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Singpetch Suksompong, Doctor	Mahidol University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided