Perifollicular Doppler in Natural Cycle In Vitro Fertilization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01668212
First received: June 19, 2012
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Infertility
Procedure: Doppler ultrasound

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Perifollicular Doppler in Natural Cycle In Vitro Fertilization

Resource links provided by NLM:


Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Quality perifollicular doppler and quality of the oocyte [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 160
Study Start Date: March 2012
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
natural In Vitro Fertilization cycle
Patient doing following natural In Vitro fertilization cycle
Procedure: Doppler ultrasound
Doppler Ultrasound

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women following In Vitro Fertilization cycle

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668212

Locations
Canada, Quebec
Ovo Fertilité
Montréal, Quebec, Canada, H4P 2S4
Sponsors and Collaborators
OVO R & D
Investigators
Principal Investigator: Delphine Delrieu, MD Clinique ovo
  More Information

No publications provided

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01668212     History of Changes
Other Study ID Numbers: OVO-11-01
Study First Received: June 19, 2012
Last Updated: June 21, 2013
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on August 28, 2014