FertilityPhase 4INOVEENCT06154083
INtensity of OVarian Stimualtion and Euploid Embryos
A Phase 4 study testing Follitropin-delta (Rekovelle) 20 mcg/day from D1 and Follitropin-delta (Rekovelle) 15 mcg/day from D1 in people with Fertility, run by Fundación Santiago Dexeus Font at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 38 to 42 years, women only
- Conditions the study is for
- Fertility
- What is being tested?
- Follitropin-delta (Rekovelle) 20 mcg/day from D1 and Follitropin-delta (Rekovelle) 15 mcg/day from D1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2023to 15 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Quiron Dexeus
Barcelona, 08028
Nikolaos P Polyzos, MD PhD, 0034932274700, nikpol@dexeus.com
Ignacio Rodriguez, MSc, 0034932274700, nacrod@dexeus.com
About this study
Official title: The Impact of Ovarian Stimulation Intensity on Embryo Euploidy in Advanced Age Women
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.
- Conditions
- Fertility
- Being tested
- Follitropin-delta (Rekovelle) 20 mcg/day from D1, Follitropin-delta (Rekovelle) 15 mcg/day from D1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 (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.
| Study group | Role | What they receive |
|---|---|---|
| Follitropin-delta 20 mcg/day from D1 | Experimental | Not described Receives: Drug: Follitropin-delta (Rekovelle) 20 mcg/day from D1 |
| Follitropin-delta 15 mcg/day from D1 | Active comparator | Not described Receives: Drug: Follitropin-delta (Rekovelle) 15 mcg/day from D1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of euploid embryos
Number of euploid embryos
Measured: Trough study completion, an average of 20-30 days.
Secondary outcomes (23)
Gonadotropin dose
Total gonadotropin dose used
Measured: Up to oocyte pickup, an average of 10-20 days
Length of stimulation
Days of stimulation
Measured: Up to oocyte pickup, an average of 10-20 days
Estradiol
Estradiol level
Measured: Up to oocyte pickup, an average of 10-20 days
Progesterone
Progesterone level
Measured: Up to oocyte pickup, an average of 10-20 days
LH
LH level
Measured: Up to oocyte pickup, an average of 10-20 days
Follicular Output RaTe (FORT)
ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation
Measured: Day one of stimulation. 1 Day
Cycle cancelation rate
Cycle cancelation rate
Measured: Up to oocyte pickup, an average of 10-20 days
Fertilization rate
Fertilization rate
Measured: Up to one day after oocyte pickup, an average of 10-20 days
Time of appearance of the 2nd polar body (tPB2)
Time of appearance of the 2nd polar body (tPB2)
Measured: Up to one day after oocyte pickup, an average of 10-20 days
Time of pronuclei disappearance (tPNf)
Measured: Up to one day after oocyte pickup, an average of 10-20 days
Time of division from 2 to 8 cells
Measured: Until 1, or 4 days after insemination
Time of compactation (tSC)
Measured: Until 3, or 4 days after insemination
Time of morula (tM)
Measured: Until 4 or 7 days after insemination
Time of cavitation (tSB)
Measured: Until 4 or 7 days after insemination
Time of full blastulation (tB)
Measured: Until 4 or 7 days after insemination
Total number of day 5 blastocysts
Measured: Until 5, 6 or 7 days after insemination
Total number of good quality blastocysts
Measured: Until 5, 6 or 7 days after insemination
Total number of embryos
Measured: Until 5, 6 or 7 days after insemination
Blastocyst formation rate
proportion of 2PN zygotes that reach the blastocyst stage
Measured: Until 5, 6 or 7 days after insemination
Number of embryos cryopreserved
Measured: Until 5, 6 or 7 days after insemination
Embryo stage
Measured: Until 5, 6 or 7 days after insemination
Clinical pregnancy rate
defined as the visualization of one or more gestational sacs
Measured: 5-6 weeks after transfer
Ongoing pregnancy rate
defined as a viable intrauterine pregnancy
Measured: 8-10 weeks after transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start12 Dec 2023
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Santiago Dexeus Font
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154083
- Sponsor's protocol ID
- FSD-INO-2023-14
- Other IDs
- 2023-507028-22, 2023
- Acronym
- INOVEE
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28169189Arce 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.
PubMed 32819842Baart 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.
PubMed 17204525Briggs 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.
PubMed 25362088Devesa 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.
PubMed 30272168Franasiak 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.
PubMed 24355045Irani 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.
PubMed 32348476Kok 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.
PubMed 16580375La 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.
PubMed 28987789Neves 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.
PubMed 36707342Polyzos 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.
PubMed 30196963Ubaldi 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.
PubMed 30842755Venetis 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.
PubMed 30476100Wu 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.
PubMed 30137360
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ovarian Stimulation Intensity on Embryo Euploidy in Advanced Age Women
- ClinicalTrials.gov ID
- NCT06154083
- Acronym / sponsor ID
- INOVEE / FSD-INO-2023-14
- Conditions
- Fertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fundación Santiago Dexeus FontUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 38 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follitropin-delta (Rekovelle) 20 mcg/day from D1On 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. | Drug | Follitropin-delta 20 mcg/day from D1 |
| Follitropin-delta (Rekovelle) 15 mcg/day from D1On 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. | Drug | Follitropin-delta 15 mcg/day from D1 |
Primary outcome
Number of euploid embryos
Time frame: Trough study completion, an average of 20-30 days.
Number of euploid embryos
23 secondary outcomes
Gonadotropin dose
Time frame: Up to oocyte pickup, an average of 10-20 days
Length of stimulation
Time frame: Up to oocyte pickup, an average of 10-20 days
Estradiol
Time frame: Up to oocyte pickup, an average of 10-20 days
Progesterone
Time frame: Up to oocyte pickup, an average of 10-20 days
LH
Time frame: Up to oocyte pickup, an average of 10-20 days
Follicular Output RaTe (FORT)
Time frame: Day one of stimulation. 1 Day
Cycle cancelation rate
Time frame: Up to oocyte pickup, an average of 10-20 days
Fertilization rate
Time frame: Up to one day after oocyte pickup, an average of 10-20 days
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 pronuclei disappearance (tPNf)
Time frame: Up to one day after oocyte pickup, an average of 10-20 days
Time of division from 2 to 8 cells
Time frame: Until 1, or 4 days after insemination
Time of compactation (tSC)
Time frame: Until 3, or 4 days after insemination
Time of morula (tM)
Time frame: Until 4 or 7 days after insemination
Time of cavitation (tSB)
Time frame: Until 4 or 7 days after insemination
Time of full blastulation (tB)
Time frame: Until 4 or 7 days after insemination
Total number of day 5 blastocysts
Time frame: Until 5, 6 or 7 days after insemination
Total number of good quality blastocysts
Time frame: Until 5, 6 or 7 days after insemination
Total number of embryos
Time frame: Until 5, 6 or 7 days after insemination
Blastocyst formation rate
Time frame: Until 5, 6 or 7 days after insemination
Number of embryos cryopreserved
Time frame: Until 5, 6 or 7 days after insemination
Embryo stage
Time frame: Until 5, 6 or 7 days after insemination
Clinical pregnancy rate
Time frame: 5-6 weeks after transfer
Ongoing pregnancy rate
Time frame: 8-10 weeks after transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 28169189Alper 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.
- Background: PubMed 32819842Arce 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.
- Background: PubMed 17204525Baart 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.
- Background: PubMed 25362088Briggs 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.
- Background: PubMed 30272168Devesa 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.
- Background: PubMed 24355045Franasiak 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.
- Background: PubMed 32348476Irani 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.
- Background: PubMed 16580375Kok 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.
- Background: PubMed 28987789La 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.
- Background: PubMed 36707342Neves 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.
- Background: PubMed 30196963Polyzos 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.
- Background: PubMed 30842755Ubaldi 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Follitropin-delta (Rekovelle) 20 mcg/day from D1 and Follitropin-delta (Rekovelle) 15 mcg/day from D1 in people with Fertility, run by Fundación Santiago Dexeus Font at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikolaos P Polyzos, MD, PhD (0034932274700, nikpol@dexeus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of euploid embryos (time frame: Trough study completion, an average of 20-30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06154083, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.