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CRYOPRESERVATION STUDY ON PROGRESS… Only couples who meet the inclusion/exclusion criteria and in which In Vitro Fertilization (IVF) is the indicated form of treatment for achieving pregnancy will be offered enrollment in this clinical trial… “CLINICAL EFFICACY OF AN r-FSH-ANTAGONIST PROTOCOL IN COMBINATION WITH SINGLE EMBRYO TRANSFER (SET) AND CRYOSTORAGE VIA VITRIFICATION (VIT)” Study Objectives: 1. To evaluate the effects of individualized controlled ovarian stimulation protocols with r-FSH/antagonist in the production of oocytes, embryos and pregnancy outcomes in in vitro fertilization patients. 2. To evaluate IVF treatment outcomes (viable pregnancy rate, singleton pregnancies) with the implementation of a single embryo transfer protocol in a clinical setting. 3. To evaluate oocyte/embryo survival and pregnancy outcomes after cryopreservation by vitrification. Benefits In couples who need In Vitro Fertilization in order to achieve pregnancy, ovarian stimulation medication costs can represent as much as 30% of the overall costs (approximately $ 3,000). In this study, ovarian stimulation medications and early luteal support medications (2 weeks) will be provided at no cost. Couples enrolled in this trial will benefit from a significantly discounted fee for an initial (fresh) IVF cycle and/or a cryopreserved cycle (if no pregnancy results from the fresh cycle and the couple has vitrified oocytes/embryos). In addition, Fees for cryopreservation and 6 month storage of vitrified oocytes and/or embryos are waived. Study Type, Size and duration: Prospective trial with two treatment groups, each with 20 patients per arm. Completion is expected within 18 months. subject Inclusion Criteria: 1. Infertile women up to 37 years of age and in good general physical and mental health. 2. Normal uterine cavity. 3. Normal ovarian ultrasound (at least 12 antral follicles on baseline ultrasound). 4. Normal BMI (£27) and/or weight less than 150 lbs. 5. Normal Standard Endocrine Workup for IVF (such as eugonadotropism and euthryroidism). subject Exclusion Criteria: 1. Severe male factor infertility: Less than 3 x 106 total normal motile sperm in the ejaculate, and/or Sperm DNA fragmentation index ≥ 30%, as determined by the Sperm Chromatin Structure Assay (SCSA). 2. Uncorrected Hydrosalpinx. 3. Uncorrected Abnormal uterine cavity. 4. History of hypo-responsiveness to ovarian stimulation. 5. History of complications or inability to tolerate any of the following: Oral Contraceptives, Gonadotropins, Vaginal or Intramuscular Progesterone, dermal or oral Estrogen. 6. History of any smoking in the past 3 months, or currently. 7. Active pelvic infections. Please contact our offices for additional information on this ongoing clinical trial …… 1-866-246-2273, 954-584-2273 |
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