Impact of Follicular and Blood G-CSF During a Natural Cyc... | NCT01668225

Studies
Impact of Follicular and Blood G-CSF During a Natural Cycle of IVF

NCT01668225

Sponsor

Clinique Ovo

Status

Terminated

Last Update Posted

Sep 10, 2022Actual

Enrollment

152Actual

Phase

Not provided

Conditions

Infertility

Interventions

Blood test

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

Sep 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment difficulties

Expanded Access Info

Start Date

Mar 2012Actual

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

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

Sep 8, 2022

Last Update Posted Date

Sep 10, 2022Actual

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

Recently, scientists look into G-CSF (Granulocyte - Colony Stimulatin Factor). The use of this molecule is increasing in reproduction pathology. High level of follicular and blood G-CSF on the day of oocyte retrieval could correlate with higher pregnancy and implantation rates.

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

152Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
G-CSF FIV nat		Patient following a natural In Vitro Fecondation cycle	Procedure: Blood test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood test	Procedure	Taking blood sample of the patient during the day 3, triggering day, oocyte collection day and pregnancy test day. Taking the follicular fluid during the oocyte collection day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum and / or follicular minimum level of G-CSF predictive of pregnancy		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women between 18 and 43 years old
Women natural In Vitro Fecondation

Exclusion Criteria:

No exclusion criteria

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

Women with a natural cycle of an In Vitro Fecondation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacques Kadoch, 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

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided