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The impact of ovarian stimulation intensity on embryo euploidy in advanced age women. A randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507028-22-00
Acronym
FSD-INO-2023-14
Enrollment
110
Registered
2023-11-14
Start date
2023-12-12
Completion date
Unknown
Last updated
2024-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

To compare the two stimulation groups of 15 vs 20 mcg of follitropin-delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT-A with a PPOS protocol

Detailed description

Total gonadotropin dose and length of stimulation, Number of oocytes and mature oocytes (MIIs) retrieved, Endocrine profile at specific intervals (estradiol, progesterone, FSH and LH), Follicle to Oocyte Index (FOI) (ratio between the total number of oocytes collected at the end of ovarian stimulation and the number of antral follicles available at the start of stimulation)., Follicular Output RaTe (FORT) (ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation)., Cycle cancelation rate, Reason for cycle cancelation, Fertilization rate, Time of appearance of the 2nd polar body (tPB2), Time of pronuclei appearance (tPNa), Evaluation of both pronuclei (PN), Time of pronuclei disappearance (tPNf), Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8), Time of compactation (tSC), Time of morula (tM), Time of cavitation (tSB), Time of full blastulation (tB), Total number of day 5 blastocysts, Total number of good quality blastocysts, Total number of embryos, Blastocyst formation rate, defined as the proportion of 2PN zygotes that reach the blastocyst stage, Number of embryos cryopreserved, Embryo stage (D5, D6, D7), Clinical pregnancy rate, defined as the visualization of one or more gestational sacs, Ongoing pregnancy rate, defined as a viable intrauterine pregnancy of at least 8-10 weeks duration confirmed on an ultrasound scan

Interventions

Sponsors

Santiago Dexeus Font Fundacio Privada
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
To compare the two stimulation groups of 15 vs 20 mcg of follitropin-delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT-A with a PPOS protocol

Secondary

MeasureTime frame
Total gonadotropin dose and length of stimulation, Number of oocytes and mature oocytes (MIIs) retrieved, Endocrine profile at specific intervals (estradiol, progesterone, FSH and LH), Follicle to Oocyte Index (FOI) (ratio between the total number of oocytes collected at the end of ovarian stimulation and the number of antral follicles available at the start of stimulation)., Follicular Output RaTe (FORT) (ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation)., Cycle cancelation rate, Reason for cycle cancelation, Fertilization rate, Time of appearance of the 2nd polar body (tPB2), Time of pronuclei appearance (tPNa), Evaluation of both pronuclei (PN), Time of pronuclei disappearance (tPNf), Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8), Time of compactation (tSC), Time of morula (tM), Time of cavitation (tSB), Time of full blastulation (tB), Total number of day 5 blastocysts, Total number of good quali

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026