INtensity of OVarian Stimualtion and Euploid Embryos (INOVEE)

February 25, 2025 updated by: Fundación Santiago Dexeus Font

The Impact of Ovarian Stimulation Intensity on Embryo Euploidy in Advanced Age Women

This randomized trial was designed as a no-inferiority trial aiming to evaluate if the intensity of stimulation (a milder vs a more intense approach) may have an impact on the number of euploid embryos and the morpho kinetic parameters in advanced age women undergoing PGT-A with a PPOS protocol.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

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 Contact

  • Name: Ignacio Rodríguez, MSc
  • Phone Number: 22029 0034932274700
  • Email: nacrod@dexeus.com

Study Contact Backup

  • Name: Nikolaos P Polyzos, MD, PhD
  • Phone Number: 0034932274700
  • Email: nikpol@dexeus.com

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • Hospital Universitario Quiron Dexeus
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nikolaos P Polyzos, MD PhD
        • Sub-Investigator:
          • Valeria Donno, MD

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infertile patients with indication for IVF
  • Undergoing preimplantation genetic screening cycles
  • AMH >= 1.5 ng/ml and < 3.5 ng/ml (AMH result of up to one year will be valid)
  • BMI 18.5 - 30 Kg/m2

Exclusion Criteria:

  • Severe male factor requiring TESE (testicular sperm extraction)
  • AMH < 1.5 ng/ml or >= 3.5 ng/ml
  • Administration of any other drug potentially interfering with the treatment
  • Contraindication for hormonal treatment
  • Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
  • Monogenic disease to be detected with PGT-M

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Follitropin-delta 20 mcg/day from D1
Drug: Follitropin-delta (Rekovelle) 20 mcg/day from D1
On day 2 or 3 of the menstrual cycle, daily injections of 20 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
Active Comparator: Follitropin-delta 15 mcg/day from D1
Drug: Follitropin-delta (Rekovelle) 15 mcg/day from D1
On day 2 or 3 of the menstrual cycle, daily injections of 15 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls and blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of euploid embryos
Time Frame: Trough study completion, an average of 20-30 days.
Number of euploid embryos
Trough study completion, an average of 20-30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of embryos
Time Frame: Until 5, 6 or 7 days after insemination
Until 5, 6 or 7 days after insemination
Number of embryos cryopreserved
Time Frame: Until 5, 6 or 7 days after insemination
Until 5, 6 or 7 days after insemination
Gonadotropin dose
Time Frame: Up to oocyte pickup, an average of 10-20 days
Total gonadotropin dose used
Up to oocyte pickup, an average of 10-20 days
Length of stimulation
Time Frame: Up to oocyte pickup, an average of 10-20 days
Days of stimulation
Up to oocyte pickup, an average of 10-20 days
Estradiol
Time Frame: Up to oocyte pickup, an average of 10-20 days
Estradiol level
Up to oocyte pickup, an average of 10-20 days
Progesterone
Time Frame: Up to oocyte pickup, an average of 10-20 days
Progesterone level
Up to oocyte pickup, an average of 10-20 days
LH
Time Frame: Up to oocyte pickup, an average of 10-20 days
LH level
Up to oocyte pickup, an average of 10-20 days
Follicular Output RaTe (FORT)
Time Frame: Day one of stimulation. 1 Day
ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation
Day one of stimulation. 1 Day
Cycle cancelation rate
Time Frame: Up to oocyte pickup, an average of 10-20 days
Cycle cancelation rate
Up to oocyte pickup, an average of 10-20 days
Fertilization rate
Time Frame: Up to one day after oocyte pickup, an average of 10-20 days
Fertilization rate
Up to one day after oocyte pickup, an average of 10-20 days
Time of appearance of the 2nd polar body (tPB2)
Time Frame: Up to one day after oocyte pickup, an average of 10-20 days
Time of appearance of the 2nd polar body (tPB2)
Up to one day after oocyte pickup, an average of 10-20 days
Time of pronuclei disappearance (tPNf)
Time Frame: Up to one day after oocyte pickup, an average of 10-20 days
Up to one day after oocyte pickup, an average of 10-20 days
Time of division from 2 to 8 cells
Time Frame: Until 1, or 4 days after insemination
Until 1, or 4 days after insemination
Time of compactation (tSC)
Time Frame: Until 3, or 4 days after insemination
Until 3, or 4 days after insemination
Time of morula (tM)
Time Frame: Until 4 or 7 days after insemination
Until 4 or 7 days after insemination
Time of cavitation (tSB)
Time Frame: Until 4 or 7 days after insemination
Until 4 or 7 days after insemination
Time of full blastulation (tB)
Time Frame: Until 4 or 7 days after insemination
Until 4 or 7 days after insemination
Total number of day 5 blastocysts
Time Frame: Until 5, 6 or 7 days after insemination
Until 5, 6 or 7 days after insemination
Total number of good quality blastocysts
Time Frame: Until 5, 6 or 7 days after insemination
Until 5, 6 or 7 days after insemination
Blastocyst formation rate
Time Frame: Until 5, 6 or 7 days after insemination
proportion of 2PN zygotes that reach the blastocyst stage
Until 5, 6 or 7 days after insemination
Embryo stage
Time Frame: Until 5, 6 or 7 days after insemination
Until 5, 6 or 7 days after insemination
Clinical pregnancy rate
Time Frame: 5-6 weeks after transfer
defined as the visualization of one or more gestational sacs
5-6 weeks after transfer
Ongoing pregnancy rate
Time Frame: 8-10 weeks after transfer
defined as a viable intrauterine pregnancy
8-10 weeks after transfer

Collaborators and Investigators

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

Sponsor

Fundación Santiago Dexeus Font

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

December 12, 2023

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSD-INO-2023-14
  • 2023-507028-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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