The Rate of Embryo Euploidy in Progestin-primed Ovarian Stimulation Cycles
NCT ID: NCT04654741
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
396 participants
INTERVENTIONAL
2020-09-01
2022-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Progestin Primed ovarian stimulation Group
progestin 10 mg daily during ovarian stimulation
Medroxyprogesterone Acetate
1 pill per day
GnRH antagonist
GnRH antagonist 0.25 mg daily during ovarian stimulation
Ganirelix Acetate
1 injection per day
Interventions
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Medroxyprogesterone Acetate
1 pill per day
Ganirelix Acetate
1 injection per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* recurrent miscarriage,
* repeated implantation failure,
* severe male infertility,
* patients who desire information regarding the health status of their embryos.
Exclusion Criteria
* previous surgery,
* abnormal karyotype,
* genetic or systematic disease
18 Years
40 Years
FEMALE
No
Sponsors
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Casa di Cura Privata Villa Mafalda
NETWORK
Responsible Party
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Locations
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Villa Mafalda
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Ermanno Greco, MD
Role: primary
Other Identifiers
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4/2018
Identifier Type: -
Identifier Source: org_study_id