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NCT Number: NCT06154083

INtensity of OVarian Stimualtion and Euploid Embryos

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.

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Key information

Conditions

Fertility

Age range

38 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Quiron Dexeus

Barcelona, 08028, Spain

Location status: Recruiting

Location contact

Ignacio Rodriguez, MSc

CONTACT

[email protected]

0034932274700

Nikolaos P Polyzos, MD PhD

CONTACT

[email protected]

0034932274700

Nikolaos P Polyzos, MD PhD

PRINCIPAL_INVESTIGATOR

Valeria Donno, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follitropin-delta (Rekovelle) 20 mcg/day from D1

Drug

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.

Follitropin-delta (Rekovelle) 15 mcg/day from D1

Drug

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.

Primary outcomes

  1. Number of euploid embryos

    Time frame: Trough study completion, an average of 20-30 days.

    Number of euploid embryos

Secondary outcomes

  1. Gonadotropin dose

    Time frame: Up to oocyte pickup, an average of 10-20 days

    Total gonadotropin dose used

  2. Length of stimulation

    Time frame: Up to oocyte pickup, an average of 10-20 days

    Days of stimulation

  3. Estradiol

    Time frame: Up to oocyte pickup, an average of 10-20 days

    Estradiol level

  4. Progesterone

    Time frame: Up to oocyte pickup, an average of 10-20 days

    Progesterone level

  5. LH

    Time frame: Up to oocyte pickup, an average of 10-20 days

    LH level

  6. 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

  7. Cycle cancelation rate

    Time frame: Up to oocyte pickup, an average of 10-20 days

    Cycle cancelation rate

  8. Fertilization rate

    Time frame: Up to one day after oocyte pickup, an average of 10-20 days

    Fertilization rate

  9. 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)

  10. Time of pronuclei disappearance (tPNf)

    Time frame: Up to one day after oocyte pickup, an average of 10-20 days

  11. Time of division from 2 to 8 cells

    Time frame: Until 1, or 4 days after insemination

  12. Time of compactation (tSC)

    Time frame: Until 3, or 4 days after insemination

  13. Time of morula (tM)

    Time frame: Until 4 or 7 days after insemination

  14. Time of cavitation (tSB)

    Time frame: Until 4 or 7 days after insemination

  15. Time of full blastulation (tB)

    Time frame: Until 4 or 7 days after insemination

  16. Total number of day 5 blastocysts

    Time frame: Until 5, 6 or 7 days after insemination

  17. Total number of good quality blastocysts

    Time frame: Until 5, 6 or 7 days after insemination

  18. Total number of embryos

    Time frame: Until 5, 6 or 7 days after insemination

  19. Blastocyst formation rate

    Time frame: Until 5, 6 or 7 days after insemination

    proportion of 2PN zygotes that reach the blastocyst stage

  20. Number of embryos cryopreserved

    Time frame: Until 5, 6 or 7 days after insemination

  21. Embryo stage

    Time frame: Until 5, 6 or 7 days after insemination

  22. Clinical pregnancy rate

    Time frame: 5-6 weeks after transfer

    defined as the visualization of one or more gestational sacs

  23. Ongoing pregnancy rate

    Time frame: 8-10 weeks after transfer

    defined as a viable intrauterine pregnancy

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Rodríguez, MSc

CONTACT

[email protected]

0034932274700 ext. 22029

Nikolaos P Polyzos, MD, PhD

CONTACT

[email protected]

0034932274700

Sponsors and collaborators

Lead sponsor

Fundación Santiago Dexeus Font

Other

Registry information

Official study title

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

Acronym: INOVEE

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 1, 2023
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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