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Impact of Follicular and Blood G-CSF on Pregnancy and Implantation Rate During Modified Natural in Vitro Fertility Cycle (G-CSF FIVnat)

This study is currently recruiting participants.
Verified July 2017 by OVO R & D
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668225
First Posted: August 20, 2012
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
OVO R & D
  Purpose
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.

Condition Intervention
Infertility Procedure: Blood test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Follicular and Blood G-CSF on Pregnangcy and Implantation Rate During Modified Natural in Vitro Fertility Cycle

Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Serum and / or follicular minimum level of G-CSF predictive of pregnancy [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Serum sample Follicular fluid

Estimated Enrollment: 224
Study Start Date: March 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
G-CSF FIV nat
Patient following a natural In Vitro Fecondation cycle
Procedure: Blood test

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


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with a natural cycle of an In Vitro Fecondation
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668225


Contacts
Contact: Cynthia Levesque (514) 798-2000 ext 755 c.levesque@cliniqueovo.com
Contact: Michael Harnois (514) 798-2000 ext 755 m.harnois@cliniqueovo.com

Locations
Canada, Quebec
Ovo Fertilité Recruiting
Montréal, Quebec, Canada, J4P 2S4
Contact: Shirley Brugerie, Director    (514) 798-2000 ext 753    s.brugerie@cliniqueovo.com   
Contact: Cynthia Levesque, Research assistant    514-798-2000 ext 755    c.levesque@cliniqueovo.com   
Sponsors and Collaborators
OVO R & D
Investigators
Principal Investigator: Pierre Lehmann, MD Clinique ovo
  More Information

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01668225     History of Changes
Other Study ID Numbers: OVO-11-02
First Submitted: June 19, 2012
First Posted: August 20, 2012
Last Update Posted: July 25, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female