Perifollicular Vascularity Assessment in in-Vitro Fertilization

NCT00458380 | Completed Phase 4

• 1 other identifier: 09/2004
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Keywords

Doppler ultrasonography; Embryos; Infertility; IVF; Oocytes; Tubal factor; unexplained infertility

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

Secondary Outcomes (1)

• Implantation rate

Interventions

Controlled ovarian stimulation, perifollicular vascularity assessment, IVF, embryo transfer. PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

"Pugliese" Hospital

Catanzaro, 88100, Italy

Location

Related Publications (1)

• Palomba S, Russo T, Falbo A, Orio F Jr, Manguso F, Nelaj E, Tolino A, Colao A, Dale B, Zullo F. Clinical use of the perifollicular vascularity assessment in IVF cycles: a pilot study. Hum Reprod. 2006 Apr;21(4):1055-61. doi: 10.1093/humrep/dei441. Epub 2005 Dec 22.

  PMID: 16373407 RESULT

MeSH Terms

Conditions

Infertility

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Stefano Palomba, MD

  Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2007
• First Posted: April 10, 2007
• Study Start: September 1, 2004
• Study Completion: February 1, 2005
• Last Updated: April 10, 2007

Record last verified: 2007-04

Locations

IT (1)