Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04654741
Status:
UNKNOWN
Last Update Posted:
2020-12-04
First Post:
2020-11-22
Brief Title:
The Rate of Embryo Euploidy in Progestin-primed Ovarian Stimulation Cycles
Sponsor:
Casa di Cura Privata Villa Mafalda
Organization:
Casa di Cura Privata Villa Mafalda
Study Overview
Official Title:
The Rate of Embryo Euploidy in Women Treated With Progestin-primed Ovarian Stimulation Versus Conventional Ovarian Stimulation a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPOS
Brief Summary:
The main objective of this non-inferiority randomized controlled trial is to assess the rate of blastocyst euploidy and the number of euploid blastocysts in women undergoing IVFICSI and treated with PPOS versus conventional ovarian stimulation based on the use of GnRH antagonist The hypothesis is that PPOS is associated with a rate of blastocyst euploidy similar to what found with the conventional ovarian stimulation In other words the number of euploid blastocysts that can be obtained with the PPOS strategy is expected to be the same obtained with conventional ovarian stimulation
Moreover we expect to find non significant differences in all intermediate outcome of the IVF cycles such as in the rate of premature LH surge in the rate of patients with elevation of Progesterone on the triggering day in FSH consumption and length of stimulation in the rate of poor response and hyperresponse in number of retrieved and mature oocytes in fertilization and blastulation rate in the number of available blastocysts and in the morphological quality of blastocysts
Moreover we expect to find non significant differences in all intermediate outcome of the IVF cycles such as in the rate of premature LH surge in the rate of patients with elevation of Progesterone on the triggering day in FSH consumption and length of stimulation in the rate of poor response and hyperresponse in number of retrieved and mature oocytes in fertilization and blastulation rate in the number of available blastocysts and in the morphological quality of blastocysts
Detailed 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-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 indexBMI 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 embryos 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
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 indexBMI 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 embryos 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None