Infertility Clinical Trial
Official title:
Gametes Transfer vs. Embryo Transfer for Women Undergoing Assisted Reproductive Techniques: a Randomized Controlled Trial
Background: The cost for the treatment of infertility are limiting for the health care
access, particularly if we consider that the success rate per cycle is approximately 35%.
Alternative regimens for controlled ovarian stimulation (COS)have been described in the
medical literature, that lead to a lower cost, fewer injections and less risk of adverse
events, particularly ovarian hyperstimulation syndrome. Furthermore, some services report
excellent results with less manipulation as possible, which reduces the cost of laboratory
of human and ethically be considered less complicated once fertilization occurs in the
uterus and not in vitro.
Objectives: The main objective is to compare the reproductive outcomes between intrauterine
transfer of gametes (TG) and embryos (TE), the secondary objective is to estimate the
average number of eggs that are raised when using an EOC reduced cost.
Methods: This study will be conducted in the area of Human Reproduction, Department of
Gynecology and Obstetrics Hospital of the FMRP-USP. We will conduct an open controlled study
with random allocation of the participants in a 1:1 ratio, and we plan to include 100
participants. All participants will undergo an EOC reduced cost. We will compare the chance
of the treatment (TE or TG) result in a live birth and clinical pregnancy per woman
allocated and to estimate the number of oocytes retrieved considering all participants.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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