The Rate of Embryo Euploidy in Progestin-primed Ovarian Stimulation Cycles

Short name PPOS

NCTNCT04654741Other id4/2018

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 396 participants (estimated)
Sponsor: Casa di Cura Privata Villa Mafalda · Network
Design: Randomized · Open label (no masking)
Countries: 1 country
Italy
Start: 1 Sept 2020
Primary completion: 1 Feb 2022 (estimated)
Completion: 31 Dec 2022 (estimated)
First posted: 4 Dec 2020
Last update posted: 4 Dec 2020
Conditions: IVF · Infertility

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2020202120222023

Ph 4
PPOS
NCT04654741
1 Sept 2020 to est. 31 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 IVF/ICSI 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

Interventions

Medroxyprogesterone AcetateDrug
Ganirelix AcetateDrug

Arms2

Experimental
Progestin Primed ovarian stimulation Group
progestin 10 mg daily during ovarian stimulation
Active comparator
GnRH antagonist
GnRH antagonist 0.25 mg daily during ovarian stimulation

Primary outcomes1

Outcomes the sponsor listed as primary.

blastocyst euploidy
Time frame · From the date of randomization up to the assessment of blastocyst euploidy (up to 20 weeks)
Registry description
the rate of blastocyst euploidy

Secondary outcomes(3)

premature lh surge
Time frame · From the date of randomization up to the completion of ovarian stimulation (up to 20 weeks)
Registry description
the rate of premature lh surge
oocytes
Time frame · From the date of randomization up to the completion of ovarian stimulation (up to 20 weeks)
Registry description
number of total and mature oocytes
blastocysts
Time frame · From the date of randomization up to the completion of the IVF cycle (up to 20 weeks)
Registry description
number of total and good quality blastocysts

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * advanced maternal age, * recurrent miscarriage, * repeated implantation failure, * severe male infertility, * patients who desire information regarding the health status of their embryos. Exclusion Criteria: * Ovarian cyst, * previous surgery, * abnormal karyotype, * genetic or systematic disease

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