Perifollicular Vascularity Assessment in in-Vitro Fertilization
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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 |
- Ongoing pregnancy rate
- 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 |
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| Italy | |
| "Pugliese" Hospital | |
| Catanzaro, Italy, 88100 | |
| 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 May 19, 2013