Anti-Mullerian Hormone Levels Before and After an Open My... | NCT01723085

Studies
Anti-Mullerian Hormone Levels Before and After an Open Myomectomy

NCT01723085

Sponsor

Clinique Ovo

Status

Terminated

Last Update Posted

Jul 30, 2018Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Anti-Mullerian Hormone

Interventions

Not provided

Countries

Canada

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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

It has been put on hold for the moment due to logistic problems

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Nov 5, 2012

First Submission Date that Met QC Criteria

Nov 5, 2012

First Posted Date

Nov 7, 2012Estimated

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

Jul 27, 2018

Last Update Posted Date

Jul 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. It is well known that ovarian surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other surgeries. We seek to investigate the hormone variations before and after an open myomectomy.

Hypothesis: Anti-Mullerian hormone levels drop following surgery but return to normal levels in a few months

Detailed Description

Not provided

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

Retention

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open myomectomy		All patients belong to the same group Description includes the surgical technique

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-Mullerian Hormone levels variation	Anti-Mullerian Hormone levels before and 6 months after surgery	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 42 years old
Requiring open myomectomy for any indication

Exclusion Criteria:

Incapable of informed consent
Use of hormonal contraception or Gonadotropin-releasing hormone agonists in the past 3 months
Woman over 42 years old
Post-menopause women
Positive B-human chorionic gonadotropin the day of surgery
Ovarian surgery (at the same time)
Pre-operative AMH below 0.3 ng/mL

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Women 18 to 42 tears old Indication for myomectomy by laparotomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Himaya, MD	Centre hospitalier de l'Université de Montréal (CHUM)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Saint-Luc		Montreal	Quebec	H2X 3J4	Canada