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

NCT04654741 | Unknown Phase 4

• 1 other identifier: 4/2018
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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 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

Conditions

IVF; Infertility

Keywords

PGT-A; IVF; ICSI; Blastocyst; GnRH antagonist; Progestin

Outcome Measures

Primary Outcomes (1)

• blastocyst euploidy

  the rate of blastocyst euploidy

  From the date of randomization up to the assessment of blastocyst euploidy (up to 20 weeks)

Secondary Outcomes (3)

• premature lh surge

  From the date of randomization up to the completion of ovarian stimulation (up to 20 weeks)

• oocytes

  From the date of randomization up to the completion of ovarian stimulation (up to 20 weeks)

• blastocysts

  From the date of randomization up to the completion of the IVF cycle (up to 20 weeks)

Study Arms (2)

Progestin Primed ovarian stimulation Group

EXPERIMENTAL

progestin 10 mg daily during ovarian stimulation

Drug: Medroxyprogesterone Acetate

GnRH antagonist

ACTIVE COMPARATOR

GnRH antagonist 0.25 mg daily during ovarian stimulation

Drug: Ganirelix Acetate

Interventions

Medroxyprogesterone Acetate DRUG

1 pill per day

Also known as: Farlutal

Progestin Primed ovarian stimulation Group

Ganirelix Acetate DRUG

1 injection per day

Also known as: Orgalutran

GnRH antagonist

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• advanced maternal age,
• recurrent miscarriage,
• repeated implantation failure,
• severe male infertility,
• patients who desire information regarding the health status of their embryos.

You may not qualify if:

• Ovarian cyst,
• previous surgery,
• abnormal karyotype,
• genetic or systematic disease

Sponsors & Collaborators

• Casa di Cura Privata Villa Mafalda: lead

Study Sites (1)

Villa Mafalda

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Medroxyprogesterone Acetate; ganirelix

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Ermanno Greco

CONTACT

+39335304960; ergreco1@virgilio.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: December 4, 2020
• Study Start: September 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: December 31, 2022
• Last Updated: December 4, 2020

Record last verified: 2020-11

Locations

IT (1)