Perifollicular Doppler in Natural Cycle In Vitro Fertiliz... | NCT01668212

Studies
Perifollicular Doppler in Natural Cycle In Vitro Fertilization

NCT01668212

Sponsor

Clinique Ovo

Status

Completed

Last Update Posted

Jun 24, 2013Estimated

Enrollment

160Actual

Phase

Not provided

Conditions

Infertility

Interventions

Doppler ultrasound

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

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

May 2013Actual

Completion Date

Not provided

First Submitted Date

Jun 19, 2012

First Submission Date that Met QC Criteria

Aug 14, 2012

First Posted Date

Aug 20, 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

Jun 21, 2013

Last Update Posted Date

Jun 24, 2013Estimated

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

Perifollicular Doppler could reflect the quality of the follicle's vascularization and, consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.

The goal of this study is to evaluate if there is a link, in natural cycle In Vitro Fertilization, between the quality of the vascularization and the one of the oocyte, the embryo and the pregnancy.

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

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
natural In Vitro Fertilization cycle		Patient doing following natural In Vitro fertilization cycle	Procedure: Doppler ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doppler ultrasound	Procedure	Doppler Ultrasound	natural In Vitro Fertilization cycle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality perifollicular doppler and quality of the oocyte	The measurements are done twice; on days of induction and oocyte retrieval. During the blood sample collection on the day of the induction, there is also a measurement of progesterone, estradiol and luteinizing hormone (LH).	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with a natural In Vitro Fertilization cycle.
Patient under 38 years old
Body mass indice under 35
Ovulatory cycles between 20-35 days

Exclusion Criteria:

Patient with a stimulation In Vitro Fertilization cycle
Patient with a naturalIn Vitro Fertilization cycle with egg donor
Patient with a natural In Vitro Fertilization cycle with freezing embryo
Smoking patient
Diabetic patient
Patient with treatment of antihypertensive drug, anticoagulant, antiplatelet, vasodilator
Body mass indice over 35
Patient over 38 years old
Patient without ovulation or cycle over 35 days
Percutaneous Epididymal Sperm Aspiration (PESA), Testicular Sperm Extraction (TESE) or micro TESE

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Women following In Vitro Fertilization cycle

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Delphine Delrieu, MD	Clinique Ovo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ovo Fertilité		Montreal	Quebec	H4P 2S4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided