Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Infertility
  • IVF
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 40 years
Gender
Only males

Description

The study proposed is a non-inferiority randomized controlled trial Only patients undergoing PGT-A could be included. PGT-A will be proposed to couples for reasons of advanced maternal age, recurrent miscarriage, repeated implantation failure, or severe male infertility, as well as to all good-progn...

The study proposed is a non-inferiority randomized controlled trial Only patients undergoing PGT-A could be included. PGT-A will be proposed to couples for reasons of advanced maternal age, recurrent miscarriage, repeated implantation failure, or severe male infertility, as well as to all good-prognosis patients who desire information regarding the health status of their embryos. 396 patients will be included in this study (198 per arm). After randomization, patients will be treated according to the PPOS or conventional ovarian stimulation strategy. For all patients the ICSI and PGT-A will be applied and the intermediate and definitive outcomes of the ART cycles will be recorded. Ovarian Stimulation Controlled ovarian stimulation will start on the second day of the menstrual cycle, with an initial dose of recombinant follicle stimulating hormone (rFSH) (chosen according to age, antral follicle count or serum AMH and body mass index,BMI) In addition to the gonadotrophin, participants will receive progestins (MPA) in the PPOS or GnRH antagonists in the conventional ovarian stimulation. Ovarian stimulation will culminate with the oocyte retrieval procedure. Oocyte Insemination, Embryo Culture, and Biopsy. All biologic procedures will be performed as already described. Only oocytes with the first polar body extruded (metaphase II) will be treated with the use of ICSI immediately after the denudation procedure. Finally, injected oocytes will be moved to single drops of cleavage medium. Depending on the embryo's development, the blastocyst stage can be reached on day 5, 6, or 7. On the day of biopsy, 5-10 trophectoderm cells will be gently aspirated into the biopsy pipette followed by a laser-assisted removal from the rest of the blastocyst. Briefly, trophectoderm cell samples and negative controls will be processed according to the Illumina protocol.

Tracking Information

NCT #
NCT04654741
Collaborators
Not Provided
Investigators
Not Provided