Perifollicular Vascularity Assessment in in-Vitro Fertilization

This study has been completed.
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00458380
First received: April 6, 2007
Last updated: April 9, 2007
Last verified: April 2007
  Purpose

On February 2004, a law (n. 40/2004) regulating assisted reproduction techniques (ARTs) was approved in Italy. This law aimed to regulate the treatment of infertility in Italy, contains several restrictions, such as the prohibition to fertilize more than three oocytes and the obligation to transfer simultaneously all embryos obtained. Several evidences showed that the outcome of the in-vitro fertilization (IVF) techniques is strongly correlated with quality of transferred embryos (choosing the right embryos). Furthermore, this prerequisite is actually illegal in Italy, and an optimal oocyte selection can be considered as the only one crucial factor in the determining the outcome of the IVF cycle (choosing the right oocytes). Experimental data have demonstrated that perifollicular blood flow assessment is a good marker of oocyte competence, embryo viability, implantation potential, and subsequent pregnancy rate.

The purpose of this study will be to evaluate in a clinical setting whether the assessment of the perifollicular vascularity is a feasible and useful procedure for the selection of oocytes with the best developmental potential in IVF programs when only a limited number of oocytes can be fertilized.


Condition Intervention Phase
Infertility
Procedure: Controlled ovarian stimulation, perifollicular vascularity assessment, IVF, embryo transfer.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Clinical Use of the Perifollicular Vascularity Assessment in in-Vitro Fertilization Cycles: a Pilot Study

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Ongoing pregnancy rate

Secondary Outcome Measures:
  • Implantation rate

Estimated Enrollment: 116
Study Start Date: September 2004
Estimated Study Completion Date: February 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with tubal factor or unexplained infertility undergoing IVF programs.

Exclusion Criteria:

  • Body mass index (BMI, Kg/m2) <18 and >30
  • Peritoneal factor infertility
  • Polycystic ovaries (PCO)
  • Other organic pelvic diseases
  • Abnormal partner’s semen
  • Neoplastic, metabolic, endocrinological, hepatic, and cardiovascular disorders or other concurrent medical illness
  • Abuse of alcohol
  • Current or previous use of hormonal drugs
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00458380

Locations
Italy
"Pugliese" Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Stefano Palomba, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00458380     History of Changes
Other Study ID Numbers: 09/2004
Study First Received: April 6, 2007
Last Updated: April 9, 2007
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University Magna Graecia:
Doppler ultrasonography
Embryos
Infertility
IVF
Oocytes
Tubal factor
unexplained infertility

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

ClinicalTrials.gov processed this record on September 16, 2014