NCT06154083

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
1mo left

Started Dec 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Dec 2023May 2026

First Submitted

Initial submission to the registry

November 13, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

December 12, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Expected
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

November 13, 2023

Last Update Submit

February 25, 2025

Conditions

Fertility

Outcome Measures

Primary Outcomes (1)

  • Number of euploid embryos

    Number of euploid embryos

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

Secondary Outcomes (23)

  • Gonadotropin dose

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

  • Length of stimulation

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

  • Estradiol

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

  • Progesterone

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

  • LH

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

  • +18 more secondary outcomes

Study Arms (2)

Follitropin-delta 20 mcg/day from D1

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

Follitropin-delta 15 mcg/day from D1

ACTIVE COMPARATOR
Drug: Follitropin-delta (Rekovelle) 15 mcg/day from D1

Interventions

Follitropin-delta (Rekovelle) 20 mcg/day from D1DRUG

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 20 mcg/day from D1
Follitropin-delta (Rekovelle) 15 mcg/day from D1DRUG

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.

Follitropin-delta 15 mcg/day from D1

Eligibility Criteria

Age38 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Quiron Dexeus

Barcelona, 08028, Spain

RECRUITING

Related Publications (14)

  • Alper MM, Fauser BC. Ovarian stimulation protocols for IVF: is more better than less? Reprod Biomed Online. 2017 Apr;34(4):345-353. doi: 10.1016/j.rbmo.2017.01.010. Epub 2017 Jan 24.

    PMID: 28169189BACKGROUND

  • Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.

    PMID: 32819842BACKGROUND

  • Baart EB, Martini E, Eijkemans MJ, Van Opstal D, Beckers NG, Verhoeff A, Macklon NS, Fauser BC. Milder ovarian stimulation for in-vitro fertilization reduces aneuploidy in the human preimplantation embryo: a randomized controlled trial. Hum Reprod. 2007 Apr;22(4):980-8. doi: 10.1093/humrep/del484. Epub 2007 Jan 4.

    PMID: 17204525BACKGROUND

  • Briggs R, Kovacs G, MacLachlan V, Motteram C, Baker HW. Can you ever collect too many oocytes? Hum Reprod. 2015 Jan;30(1):81-7. doi: 10.1093/humrep/deu272. Epub 2014 Oct 31.

    PMID: 25362088BACKGROUND

  • Devesa M, Tur R, Rodriguez I, Coroleu B, Martinez F, Polyzos NP. Cumulative live birth rates and number of oocytes retrieved in women of advanced age. A single centre analysis including 4500 women >/=38 years old. Hum Reprod. 2018 Nov 1;33(11):2010-2017. doi: 10.1093/humrep/dey295.

    PMID: 30272168BACKGROUND

  • Franasiak JM, Forman EJ, Hong KH, Werner MD, Upham KM, Treff NR, Scott RT Jr. The nature of aneuploidy with increasing age of the female partner: a review of 15,169 consecutive trophectoderm biopsies evaluated with comprehensive chromosomal screening. Fertil Steril. 2014 Mar;101(3):656-663.e1. doi: 10.1016/j.fertnstert.2013.11.004. Epub 2013 Dec 17.

    PMID: 24355045BACKGROUND

  • Irani M, Canon C, Robles A, Maddy B, Gunnala V, Qin X, Zhang C, Xu K, Rosenwaks Z. No effect of ovarian stimulation and oocyte yield on euploidy and live birth rates: an analysis of 12 298 trophectoderm biopsies. Hum Reprod. 2020 May 1;35(5):1082-1089. doi: 10.1093/humrep/deaa028.

    PMID: 32348476BACKGROUND

  • Kok JD, Looman CW, Weima SM, te Velde ER. A high number of oocytes obtained after ovarian hyperstimulation for in vitro fertilization or intracytoplasmic sperm injection is not associated with decreased pregnancy outcome. Fertil Steril. 2006 Apr;85(4):918-24. doi: 10.1016/j.fertnstert.2005.09.035.

    PMID: 16580375BACKGROUND

  • La Marca A, Minasi MG, Sighinolfi G, Greco P, Argento C, Grisendi V, Fiorentino F, Greco E. Female age, serum antimullerian hormone level, and number of oocytes affect the rate and number of euploid blastocysts in in vitro fertilization/intracytoplasmic sperm injection cycles. Fertil Steril. 2017 Nov;108(5):777-783.e2. doi: 10.1016/j.fertnstert.2017.08.029. Epub 2017 Oct 4.

    PMID: 28987789BACKGROUND

  • Neves AR, Montoya-Botero P, Sachs-Guedj N, Polyzos NP. Association between the number of oocytes and cumulative live birth rate: A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Mar;87:102307. doi: 10.1016/j.bpobgyn.2022.102307. Epub 2022 Dec 27.

    PMID: 36707342BACKGROUND

  • Polyzos NP, Drakopoulos P, Parra J, Pellicer A, Santos-Ribeiro S, Tournaye H, Bosch E, Garcia-Velasco J. Cumulative live birth rates according to the number of oocytes retrieved after the first ovarian stimulation for in vitro fertilization/intracytoplasmic sperm injection: a multicenter multinational analysis including approximately 15,000 women. Fertil Steril. 2018 Sep;110(4):661-670.e1. doi: 10.1016/j.fertnstert.2018.04.039.

    PMID: 30196963BACKGROUND

  • Ubaldi FM, Cimadomo D, Vaiarelli A, Fabozzi G, Venturella R, Maggiulli R, Mazzilli R, Ferrero S, Palagiano A, Rienzi L. Advanced Maternal Age in IVF: Still a Challenge? The Present and the Future of Its Treatment. Front Endocrinol (Lausanne). 2019 Feb 20;10:94. doi: 10.3389/fendo.2019.00094. eCollection 2019.

    PMID: 30842755BACKGROUND

  • Venetis CA, Tilia L, Panlilio E, Kan A. Is more better? A higher oocyte yield is independently associated with more day-3 euploid embryos after ICSI. Hum Reprod. 2019 Jan 1;34(1):79-83. doi: 10.1093/humrep/dey342.

    PMID: 30476100BACKGROUND

  • Wu Q, Li H, Zhu Y, Jiang W, Lu J, Wei D, Yan J, Chen ZJ. Dosage of exogenous gonadotropins is not associated with blastocyst aneuploidy or live-birth rates in PGS cycles in Chinese women. Hum Reprod. 2018 Oct 1;33(10):1875-1882. doi: 10.1093/humrep/dey270.

    PMID: 30137360BACKGROUND

Related Links

MeSH Terms

Interventions

follitropin delta

Central Study Contacts

Nikolaos P Polyzos, MD, PhD

CONTACT

0034932274700nikpol@dexeus.com

Ignacio Rodríguez, MSc

CONTACT

0034932274700nacrod@dexeus.com

Study Design

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

Study Record Dates

First Submitted

November 13, 2023

First Posted

December 1, 2023

Study Start

December 12, 2023

Primary Completion

December 15, 2025

Study Completion (Estimated)

May 15, 2026

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations

ES(1)