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

December 3, 2020 updated by: Casa di Cura Privata Villa Mafalda

The Rate of Embryo Euploidy in Women Treated With Progestin-primed Ovarian Stimulation Versus Conventional Ovarian Stimulation: a Randomized Controlled Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

396

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Recruiting
        • Villa Mafalda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Progestin Primed ovarian stimulation Group
progestin 10 mg daily during ovarian stimulation
Drug: Medroxyprogesterone Acetate
1 pill per day
Other Names:
  • Farlutal
ACTIVE_COMPARATOR: GnRH antagonist
GnRH antagonist 0.25 mg daily during ovarian stimulation
Drug: Ganirelix Acetate
1 injection per day
Other Names:
  • Orgalutran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blastocyst euploidy
Time Frame: From the date of randomization up to the assessment of blastocyst euploidy (up to 20 weeks)
the rate of blastocyst euploidy
From the date of randomization up to the assessment of blastocyst euploidy (up to 20 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
premature lh surge
Time Frame: From the date of randomization up to the completion of ovarian stimulation (up to 20 weeks)
the rate of premature lh surge
From the date of randomization up to the completion of ovarian stimulation (up to 20 weeks)
oocytes
Time Frame: From the date of randomization up to the completion of ovarian stimulation (up to 20 weeks)
number of total and mature oocytes
From the date of randomization up to the completion of ovarian stimulation (up to 20 weeks)
blastocysts
Time Frame: From the date of randomization up to the completion of the IVF cycle (up to 20 weeks)
number of total and good quality blastocysts
From the date of randomization up to the completion of the IVF cycle (up to 20 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa di Cura Privata Villa Mafalda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

November 22, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (ACTUAL)

December 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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