NCT01668212

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

June 19, 2012

Last Update Submit

June 21, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

natural In Vitro Fertilization cycle

Patient doing following natural In Vitro fertilization cycle

Procedure: Doppler ultrasound

Interventions

Doppler Ultrasound

natural In Vitro Fertilization cycle

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women following In Vitro Fertilization cycle

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ovo Fertilité

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Delphine Delrieu, MD

    Clinique Ovo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

August 20, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2013

Last Updated

June 24, 2013

Record last verified: 2013-06

Locations