Infertility Clinical Trial
Official title:
Clinical Use of the Perifollicular Vascularity Assessment in in-Vitro Fertilization Cycles: a Pilot Study
Verified date | April 2007 |
Source | University Magna Graecia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: The Italian Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | February 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Italy | "Pugliese" Hospital | Catanzaro |
Lead Sponsor | Collaborator |
---|---|
University Magna Graecia |
Italy,
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. Epub 2005 Dec 22. — View Citation
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---|---|---|---|---|
Primary | Ongoing pregnancy rate | |||
Secondary | Implantation rate |
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