Infertility Clinical Trial
Official title:
Follicle Activation in Patients With Poor Ovarian Response Through Fragmentation of the Ovarian Tissue.
This study aims to assess whether activation of primordial follicles through ovarian cortex fragmentation may increase the number of antral follicles present in the ovary of patients with diminished ovarian reserve. Secondary outcomes include number of oocytes retrieved and pregnancy rates after IVF. Hypothesis; Evaluate whether the proposed intervention increases the pool of antral follicles (potentially stimulable ones).
Controlled, randomized, assessor-blind clinical trial. Thirty-six patients of La Fe University Hospital (Valencia), previously confirmed as poor responders according to the European Society of Human Reproduction and Embryology (ESHRE) criteria, will be randomized to two treatment arms: - Arm 1 (control): no intervention. - Arm 2 (intervention): ovarian cortex extraction by unilateral laparoscopic biopsy and ovarian tissue fragmentation in aliquots of 1 mm2. These fragments will be grafted under the ovarian cortex and meso-ovarium ipsilateraly. Subsequently the number of antral follicles in both intervention groups will be compared and also will be the number of antral follicles in the native ovary and the grafted one in each of the patients. Patients will receive a standard IVF treatment for poor responders according to the protocols of the assisted reproduction unit of La Fe University Hospital. The final aim is to assess the pregnancy rate in both groups, as well as parameters related to the reproduction technique when required. ;
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