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

Fundación Santiago Dexeus Font1 site in 1 country110 target enrollmentDecember 12, 2023

ConditionsFertility

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

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

Overview

Phase: Phase 4
Intervention: Follitropin-delta (Rekovelle) 20 mcg/day from D1
Conditions: Fertility
Sponsor: Fundación Santiago Dexeus Font
Enrollment: 110
Locations: 1
Primary Endpoint: Number of euploid embryos
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 12, 2023

End Date

May 15, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Fundación Santiago Dexeus Font

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Follitropin-delta 20 mcg/day from D1

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

Follitropin-delta 15 mcg/day from D1

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

Outcomes

Primary Outcomes

Number of euploid embryos

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

Number of euploid embryos

Secondary Outcomes

Gonadotropin dose(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)
Length of stimulation(Up to oocyte pickup, an average of 10-20 days)
Total number of embryos(Until 5, 6 or 7 days after insemination)
Clinical pregnancy rate(5-6 weeks after transfer)
Blastocyst formation rate(Until 5, 6 or 7 days after insemination)
LH(Up to oocyte pickup, an average of 10-20 days)
Follicular Output RaTe (FORT)(Day one of stimulation. 1 Day)
Time of morula (tM)(Until 4 or 7 days after insemination)
Total number of day 5 blastocysts(Until 5, 6 or 7 days after insemination)
Total number of good quality blastocysts(Until 5, 6 or 7 days after insemination)
Ongoing pregnancy rate(8-10 weeks after transfer)
Cycle cancelation rate(Up to 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 compactation (tSC)(Until 3, or 4 days after insemination)
Time of full blastulation (tB)(Until 4 or 7 days after insemination)
Number of embryos cryopreserved(Until 5, 6 or 7 days after insemination)
Fertilization rate(Up to one day after oocyte pickup, an average of 10-20 days)
Time of cavitation (tSB)(Until 4 or 7 days after insemination)
Time of pronuclei disappearance (tPNf)(Up to one day after oocyte pickup, an average of 10-20 days)
Time of division from 2 to 8 cells(Until 1, or 4 days after insemination)
Embryo stage(Until 5, 6 or 7 days after insemination)