Actively Recruiting

Phase 4
Age: 38Years - 42Years
FEMALE
ID06154083

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

Led by Fundación Santiago Dexeus Font · Updated on 2025-02-27

110

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of ovarian stimulation intensity on the number of euploid embryos and morphokinetic parameters in women of advanced age undergoing preimplantation genetic testing for aneuploidy (PGT-A) using a progestin-primed ovarian stimulation (PPOS) protocol. This randomized, phase 4 trial aims to determine if a milder stimulation approach is as effective as a more intense one in this group of women aged 38 to 42 years who are infertile and undergoing IVF treatment. Participants will receive daily injections of Follitropin-delta (Rekovelle) starting on day 2 or 3 of their menstrual cycle. Two groups receive different doses: one group gets 20 mcg per day, and the other 15 mcg per day. Scans and blood tests will be performed at stimulation days 6, 8, and 10, with additional monitoring as needed until the trigger day. The dose remains constant throughout the stimulation period without adjustments. The study uses a randomized design without masking. During the study, researchers will assess the number of euploid embryos over approximately 20 to 30 days. Secondary measures include gonadotropin dose, length of stimulation, hormone levels, fertilization rates, embryo development timings, blastocyst quality, and pregnancy rates. Monitoring includes hormonal blood tests, ultrasound scans, and embryo evaluations up to 7 days after insemination. The total participation lasts through the stimulation and embryo evaluation cycle, with follow-up on pregnancy outcomes weeks after embryo transfer.

CONDITIONS

Brief Title

INtensity of OVarian Stimualtion and Euploid Embryos

Who Can Participate

Age: 38Years - 42Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Female gender
  • Age between 38 and 42 years
Not Eligible

You will not qualify if you...

  • 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
  • Monogenic disease to be detected with PGT-M

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 10 to 20 days

Participants receive daily injections of Follitropin-delta (either 15 mcg or 20 mcg) starting on day 2 or 3 of their menstrual cycle. Scan controls and blood exams are performed on stimulation days 6, 8, 10, and as needed until oocyte pickup.

4 to 6 visits (in-person) during stimulation

Follow-up

Duration - Up to 5 to 10 weeks after embryo transfer

Participants are monitored for embryo development and pregnancy outcomes following oocyte pickup and embryo transfer.

2 to 3 visits (in-person) after transfer

Trial Site Locations

Total: 1 location

1

Hospital Universitario Quiron Dexeus

Barcelona, Spain, 08028

Actively Recruiting

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Research Team

N

Nikolaos P Polyzos, MD, PhD

I

Ignacio Rodríguez, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa.

Joan-Carles Arce, Per Larsson, Juan Antonio García-Velasco

https://pubmed.ncbi.nlm.nih.gov/32819842

Milder ovarian stimulation for in-vitro fertilization reduces aneuploidy in the human preimplantation embryo: a randomized controlled trial.

Esther B Baart, Elena Martini, Marinus J Eijkemans...

https://pubmed.ncbi.nlm.nih.gov/17204525

Cumulative live birth rates and number of oocytes retrieved in women of advanced age. A single centre analysis including 4500 women ≥38 years old.

Marta Devesa, Rosa Tur, Ignacio Rodríguez...

https://pubmed.ncbi.nlm.nih.gov/30272168

The nature of aneuploidy with increasing age of the female partner: a review of 15,169 consecutive trophectoderm biopsies evaluated with comprehensive chromosomal screening.

Jason M Franasiak, Eric J Forman, Kathleen H Hong...

https://pubmed.ncbi.nlm.nih.gov/24355045

No effect of ovarian stimulation and oocyte yield on euploidy and live birth rates: an analysis of 12 298 trophectoderm biopsies.

M Irani, C Canon, A Robles...

https://pubmed.ncbi.nlm.nih.gov/32348476

A high number of oocytes obtained after ovarian hyperstimulation for in vitro fertilization or intracytoplasmic sperm injection is not associated with decreased pregnancy outcome.

Jeroen D Kok, Caspar W N Looman, Sjerp M Weima...

https://pubmed.ncbi.nlm.nih.gov/16580375

Female age, serum antimüllerian hormone level, and number of oocytes affect the rate and number of euploid blastocysts in in vitro fertilization/intracytoplasmic sperm injection cycles.

Antonio La Marca, Maria Giulia Minasi, Giovanna Sighinolfi...

https://pubmed.ncbi.nlm.nih.gov/28987789