InfertilityPhase 4EQUAMNCT07691073
Embryo QUAlity in Ovarian Stimulation With hMG.
A Phase 4 study testing 10 mcg of follitropin-delta + 150 of hMG and 5 mcg of follitropin-delta + 225 of hMG in people with Infertility, run by Fundacion Dexeus at 4 sites in Spain.
Trial summary
Ovarian stimulation (OS) is a key component of IVF, aimed at increasing oocyte yield and improving embryo development potential. While early protocols relied solely on FSH, newer approaches incorporate hMG and LH-based stimulation, allowing more individualized treatments for specific patient populations. Read more about this study
- Who is it for?
- Ages 38 to 41 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- 10 mcg of follitropin-delta + 150 of hMG and 5 mcg of follitropin-delta + 225 of hMG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesSpain
- Study dates
- Sep 2026to May 2029
- 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 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing preimplantation genetic screening cycles
- AMH 0.5 - 3.5 ng/ml or AFC 5-20 (results of up to one year will be valid)
- BMI 18.5 - 30 Kg/m2
- Normal karyotypes in both partners
Who cannot join
- Previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol), according to Bologna criteria
- Severe male factor requiring TESE (testicular sperm extraction)
- 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 interfere with the trial assessment)
- Monogenic disease to be detected with PGT-M
- Biochemical and/or ultrasonographic evidence of polycystic ovarian syndrome
- Endocrinological and/or autoimmune disorders
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites
Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Barcelona, 08037
Ignacio Rodríguez, BsC, 0034932274700 ext. 22029, nacrod@dexeus.com
Nikolaos P Polyzos, MD PhD
Dexeus Mujer Sabadell
Sabadell, Barcelona, 08203
Ainhoa Coco, MD, aincoc@dexeus.com
Ainhoa Coco, MD
Dexeus Mujer Sant Cugat
Sant Cugat del Vallès, Barcelona, 08195
Ainhoa Coco, MD, 0034932274700, aincoc@dexeus.com
Ainhoa Coco, MD
Dexeus Mujer Tarragona
Tarragona, 43206
Josep Gonzalo, MD
Josep Gonzalo, MD
About this study
Official title: The Impact of Ovarian Stimulation With hMG on Embryo Quality in Advanced Age Women. A Randomized Controlled Trial
Ovarian stimulation (OS) is a key component of IVF, aimed at increasing oocyte yield and improving embryo development potential. While early protocols relied solely on FSH, newer approaches incorporate hMG and LH-based stimulation, allowing more individualized treatments for specific patient populations. Evidence suggests that hMG and recombinant FSH (rFSH) have comparable effectiveness in stimulation outcomes, and current guidelines support the use of both. However, the impact of different gonadotropins on embryo quality remains unclear, with mixed findings across protocols. Given the increasing use of combined rFSH and hMG and the limited data in PPOS protocols, this study proposes a randomized controlled trial to compare embryo quality between two different rFSH-hMG dosing strategies.
- Conditions
- Infertility
- Being tested
- 10 mcg of follitropin-delta + 150 of hMG, 5 mcg of follitropin-delta + 225 of hMG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mcg of follitropin-delta + 150 of hMGDrug
On day 2 or 3 of the menstrual cycle, daily injections of 10 mcg of Rekovelle + 150 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
5 mcg of follitropin-delta + 225 of hMGDrug
On day 2 or 3 of the menstrual cycle, daily injections of 5 mcg of Rekovelle + 225 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. 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 |
|---|---|---|
| 10 mcg of Rekovelle + 150 IU of Menopur | Experimental | On day 2 or 3 of the menstrual cycle, daily injections of 10 mcg of Rekovelle + 150 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed. Receives: Drug: 10 mcg of follitropin-delta + 150 of hMG |
| 5 mcg of Rekovelle + 225 IU of Menopur | Active comparator | On day 2 or 3 of the menstrual cycle, daily injections of 5 mcg of Rekovelle + 225 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed. Receives: Drug: 5 mcg of follitropin-delta + 225 of hMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good quality blastocysts
number of good quality blastocysts based on the Istanbul consensus workshop criteria
Measured: From Day 5 to Day 7 after insemination
Secondary outcomes (32)
Total Gonadotropin Dose Administered
Cumulative dose of gonadotropins (IU) administered during ovarian stimulation.
Measured: From initiation of ovarian stimulation until day of trigger (up to 15 days)
Duration of Ovarian Stimulation
Number of days of gonadotropin administration required to reach criteria for triggering final oocyte maturation.
Measured: From first day of stimulation until trigger day (up to 15days)
Total Number of Oocytes Retrieved
Total number of oocytes collected during oocyte retrieval procedure following ovarian stimulation.
Measured: At oocyte retrieval
Number of mature oocytes (MII) retrieved
Number of metaphase II (MII) oocytes identified among retrieved oocytes
Measured: At oocyte retrieval
Serum levels of estradiol (E2)
Serum levels of estradiol (E2) measured at predefined time points during stimulation
Measured: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of progesterone (P4)
Serum levels progesterone (P4) measured at predefined time points during stimulation
Measured: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of follicle-stimulating hormone (FSH)
Serum levels follicle-stimulating hormone (FSH) measured at predefined time points during stimulation
Measured: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of luteinizing hormone (LH)
Serum levels luteinizing hormone (LH) measured at predefined time points during stimulation
Measured: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Follicle-to-Oocyte Index (FOI)
Ratio between the total number of oocytes retrieved and the number of antral follicles counted at baseline before stimulation.
Measured: From baseline AFC assessment to oocyte retrieval
Follicular Output RaTe (FORT)
Ratio between the number of preovulatory follicles on the day of trigger and the number of antral follicles at baseline.
Measured: From baseline AFC assessment to trigger day
Cycle cancellation rate
Proportion of initiated ovarian stimulation cycles that are cancelled before oocyte retrieval.
Measured: From start of stimulation to planned oocyte retrieval
Reason for cycle cancellation
Categorization of causes leading to cycle cancellation (e.g., poor response, hyper-response/risk of OHSS, premature ovulation, patient decision, or medical reasons).
Measured: At time of cycle cancellation
Fertilization Rate
Proportion of oocytes that are successfully fertilized (2PN) relative to the number of inseminated or injected (ICSI) oocytes.
Measured: Assessed 16-20 hours post-insemination or ICSI
Time of appearance of the 2nd polar body (tPB2)
ime from insemination or ICSI to the extrusion of the second polar body, indicating completion of oocyte activation.
Measured: Within 0-6 hours post-ICSI/insemination
Time of pronuclei appearance (tPNa)
Time from insemination or ICSI to the first visualization of pronuclei.
Measured: Within 0-20 hours post-ICSI/insemination
Evaluation of both pronuclei
Time from insemination or ICSI to the visualization of both pronuclei.
Measured: Within 0-20 hours post-ICSI/insemination
Time to Pronuclear Fading (tPNf)
Time from insemination or ICSI to disappearance of pronuclei
Measured: Within 20-30 hours post-ICSI/insemination
Timing of Early Cleavage Stages (t2-t8)
Time to reach each embryonic cell stage from 2 to 8 cells
Measured: From fertilization to Day 3 (up to 72 hours)
Time of compaction (tSC)
Time from fertilization to the beginning of blastomere compaction.
Measured: Day 3-4 post-fertilization (up to ~96 hours)
Time of morula (tM)
Time from fertilization to the formation of a compact morula stage embryo.
Measured: Day 4 post-fertilization (up to 120 hours)
Time of cavitation (tSB)
Time from fertilization to the initiation of blastocoel cavity formation.
Measured: Day 4-5 post-fertilization (up to ~120-132 hours)
Time of full blastulation (tB)
Time from fertilization to formation of a fully expanded blastocyst.
Measured: Day 5-6 post-fertilization (up to ~144 hours)
Total number of Day 5 blastocysts
Number of embryos reaching the blastocyst stage by Day 5 of development.
Measured: Day 5 post-fertilization
Total number of Day 6 blastocysts
Number of embryos reaching the blastocyst stage by Day 6 of development.
Measured: Day 5 post-fertilization
Total number of Day 7 blastocysts
Number of embryos reaching the blastocyst stage by Day 7 of development.
Measured: Day 5 post-fertilization
Total number of euploid embryos
Number of embryos identified as chromosomally normal following preimplantation genetic testing (PGT-A)
Measured: After genetic testing results (typically within 1-2 weeks post-biopsy)
MII to blastocyst formation rate
Proportion of mature (MII) oocytes that develop into blastocysts.
Measured: From oocyte retrieval to blastocyst stage (up to Day 5-7)
Number of embryos cryopreserved
Total number of embryos suitable for vitrification following culture.
Measured: At end of embryo culture (Day 5-7)
Clinical pregnancy rate
Presence of one or more intrauterine gestational sacs confirmed by ultrasound.
Measured: At 5-7 weeks of gestation
Ongoing Pregnancy Rate
Proportion of pregnancies with a viable intrauterine fetus beyond 8-10 weeks of gestation confirmed by ultrasound.
Measured: At 8-10 weeks of gestation
Miscarriage Rate
Proportion of clinical pregnancies that result in spontaneous pregnancy loss before 20 weeks of gestation.
Measured: From confirmation of clinical pregnancy up to 20 weeks of gestation
Live birth rate
Proportion of embryo transfer cycles resulting in at least one live-born infant, defined as the delivery of a living neonate after ≥24 weeks of gestation.
Measured: At delivery (up to ~40 weeks of gestation following embryo transfer)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Nikolaos P Polyzos, MD, PhD, Principal investigator, Dexeus Universitary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691073
- Sponsor's protocol ID
- FSD-QUA-2025-27
- Other IDs
- 2025-524761-25-00, 2025
- Acronym
- EQUAM
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Montoya-Botero P, Martinez F, Rodriguez-Purata J, Rodriguez I, Coroleu B, Polyzos NP. The effect of type of oral contraceptive pill and duration of use on fresh and cumulative live birth rates in IVF/ICSI cycles. Hum Reprod. 2020 Apr 28;35(4):826-836. doi: 10.1093/humrep/dez299.
PubMed 32163564Racca A, Rodriguez I, Garcia S, Arroyo G, Polyzos NP. Double versus single stimulation in young low prognosis patients followed by a fresh embryo transfer: a randomized controlled trial (DUOSTIM-fresh). Hum Reprod. 2024 Jun 6:deae104. doi: 10.1093/humrep/deae104. Online ahead of print.
PubMed 38845190Veiga A, Sandalinas M, Benkhalifa M, Boada M, Carrera M, Santalo J, Barri PN, Menezo Y. Laser blastocyst biopsy for preimplantation diagnosis in the human. Zygote. 1997 Nov;5(4):351-4. doi: 10.1017/s0967199400003920.
PubMed 9563682Witz CA, Daftary GS, Doody KJ, Park JK, Seifu Y, Yankov VI, Heiser PW; Menopur in GnRH Antagonist Cycles with Single Embryo Transfer - High Responder (MEGASET-HR) Trial Group. Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection. Fertil Steril. 2020 Aug;114(2):321-330. doi: 10.1016/j.fertnstert.2020.03.029. Epub 2020 May 13.
PubMed 32416978Ziebe S, Lundin K, Janssens R, Helmgaard L, Arce JC; MERIT (Menotrophin vs Recombinant FSH in vitro Fertilisation Trial) Group. Influence of ovarian stimulation with HP-hMG or recombinant FSH on embryo quality parameters in patients undergoing IVF. Hum Reprod. 2007 Sep;22(9):2404-13. doi: 10.1093/humrep/dem221. Epub 2007 Jul 19.
PubMed 17640944Andersen AN, Devroey P, Arce JC. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Hum Reprod. 2006 Dec;21(12):3217-27. doi: 10.1093/humrep/del284. Epub 2006 Jul 27.
PubMed 16873892Boada M, Carrera M, De La Iglesia C, Sandalinas M, Barri PN, Veiga A. Successful use of a laser for human embryo biopsy in preimplantation genetic diagnosis: report of two cases. J Assist Reprod Genet. 1998 May;15(5):302-7. doi: 10.1023/a:1022548612107.
PubMed 9604764Chapon RCB, Genro VK, Souza CAB, Cunha-Filho JS. Randomized controlled trial comparing embryonic quality in rFSH versus hMG in the IVF protocol with GnRH Antagonist. JBRA Assist Reprod. 2021 Feb 2;25(1):131-135. doi: 10.5935/1518-0557.20200064.
PubMed 33118716Conforti A, Esteves SC, Humaidan P, Longobardi S, D'Hooghe T, Orvieto R, Vaiarelli A, Cimadomo D, Rienzi L, Ubaldi FM, Zullo F, Alviggi C. Recombinant human luteinizing hormone co-treatment in ovarian stimulation for assisted reproductive technology in women of advanced reproductive age: a systematic review and meta-analysis of randomized controlled trials. Reprod Biol Endocrinol. 2021 Jun 21;19(1):91. doi: 10.1186/s12958-021-00759-4.
PubMed 34154604Filicori M, Cognigni GE, Pocognoli P, Tabarelli C, Ferlini F, Perri T, Parmegiani L. Comparison of controlled ovarian stimulation with human menopausal gonadotropin or recombinant follicle-stimulating hormone. Fertil Steril. 2003 Aug;80(2):390-7. doi: 10.1016/s0015-0282(03)00594-6.
PubMed 12909504Lunenfeld B. Historical perspectives in gonadotrophin therapy. Hum Reprod Update. 2004 Nov-Dec;10(6):453-67. doi: 10.1093/humupd/dmh044. Epub 2004 Sep 23.
PubMed 15388674
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ovarian Stimulation With hMG on Embryo Quality in Advanced Age Women. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07691073
- Acronym / sponsor ID
- EQUAM / FSD-QUA-2025-27
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 8 Jul 2026 (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.
Ovarian stimulation (OS) is a key component of IVF, aimed at increasing oocyte yield and improving embryo development potential. While early protocols relied solely on FSH, newer approaches incorporate hMG and LH-based stimulation, allowing more individualized treatments for specific patient populations. Evidence suggests that hMG and recombinant FSH (rFSH) have comparable effectiveness in stimulation outcomes, and current guidelines support the use of both. However, the impact of different gonadotropins on embryo quality remains unclear, with mixed findings across protocols. Given the increasing use of combined rFSH and hMG and the limited data in PPOS protocols, this study proposes a randomized controlled trial to compare embryo quality between two different rFSH-hMG dosing strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mcg of Rekovelle + 150 IU of Menopur | Experimental | Drug: 10 mcg of follitropin-delta + 150 of hMGOn day 2 or 3 of the menstrual cycle, daily injections of 10 mcg of Rekovelle + 150 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed. |
| 5 mcg of Rekovelle + 225 IU of Menopur | Active comparator | Drug: 5 mcg of follitropin-delta + 225 of hMGOn day 2 or 3 of the menstrual cycle, daily injections of 5 mcg of Rekovelle + 225 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed. |
Who may qualify
- Ages
- 38 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Undergoing preimplantation genetic screening cycles
- AMH 0.5 - 3.5 ng/ml or AFC 5-20 (results of up to one year will be valid)
- BMI 18.5 - 30 Kg/m2
- Normal karyotypes in both partners
Key exclusion criteria (8 listed)
- Previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol), according to Bologna criteria
- Severe male factor requiring TESE (testicular sperm extraction)
- 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 interfere 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 |
|---|---|---|
| 10 mcg of follitropin-delta + 150 of hMGOn day 2 or 3 of the menstrual cycle, daily injections of 10 mcg of Rekovelle + 150 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed. | Drug | 10 mcg of Rekovelle + 150 IU of Menopur |
| 5 mcg of follitropin-delta + 225 of hMGOn day 2 or 3 of the menstrual cycle, daily injections of 5 mcg of Rekovelle + 225 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed. | Drug | 5 mcg of Rekovelle + 225 IU of Menopur |
Primary outcome
Good quality blastocysts
Time frame: From Day 5 to Day 7 after insemination
number of good quality blastocysts based on the Istanbul consensus workshop criteria
32 secondary outcomes
Total Gonadotropin Dose Administered
Time frame: From initiation of ovarian stimulation until day of trigger (up to 15 days)
Duration of Ovarian Stimulation
Time frame: From first day of stimulation until trigger day (up to 15days)
Total Number of Oocytes Retrieved
Time frame: At oocyte retrieval
Number of mature oocytes (MII) retrieved
Time frame: At oocyte retrieval
Serum levels of estradiol (E2)
Time frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of progesterone (P4)
Time frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of follicle-stimulating hormone (FSH)
Time frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of luteinizing hormone (LH)
Time frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Follicle-to-Oocyte Index (FOI)
Time frame: From baseline AFC assessment to oocyte retrieval
Follicular Output RaTe (FORT)
Time frame: From baseline AFC assessment to trigger day
Cycle cancellation rate
Time frame: From start of stimulation to planned oocyte retrieval
Reason for cycle cancellation
Time frame: At time of cycle cancellation
Fertilization Rate
Time frame: Assessed 16-20 hours post-insemination or ICSI
Time of appearance of the 2nd polar body (tPB2)
Time frame: Within 0-6 hours post-ICSI/insemination
Time of pronuclei appearance (tPNa)
Time frame: Within 0-20 hours post-ICSI/insemination
Evaluation of both pronuclei
Time frame: Within 0-20 hours post-ICSI/insemination
Time to Pronuclear Fading (tPNf)
Time frame: Within 20-30 hours post-ICSI/insemination
Timing of Early Cleavage Stages (t2-t8)
Time frame: From fertilization to Day 3 (up to 72 hours)
Time of compaction (tSC)
Time frame: Day 3-4 post-fertilization (up to ~96 hours)
Time of morula (tM)
Time frame: Day 4 post-fertilization (up to 120 hours)
Time of cavitation (tSB)
Time frame: Day 4-5 post-fertilization (up to ~120-132 hours)
Time of full blastulation (tB)
Time frame: Day 5-6 post-fertilization (up to ~144 hours)
Total number of Day 5 blastocysts
Time frame: Day 5 post-fertilization
Total number of Day 6 blastocysts
Time frame: Day 5 post-fertilization
Total number of Day 7 blastocysts
Time frame: Day 5 post-fertilization
Total number of euploid embryos
Time frame: After genetic testing results (typically within 1-2 weeks post-biopsy)
MII to blastocyst formation rate
Time frame: From oocyte retrieval to blastocyst stage (up to Day 5-7)
Number of embryos cryopreserved
Time frame: At end of embryo culture (Day 5-7)
Clinical pregnancy rate
Time frame: At 5-7 weeks of gestation
Ongoing Pregnancy Rate
Time frame: At 8-10 weeks of gestation
Miscarriage Rate
Time frame: From confirmation of clinical pregnancy up to 20 weeks of gestation
Live birth rate
Time frame: At delivery (up to ~40 weeks of gestation following embryo 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 Jul 2026.
- Background: PubMed 32163564Montoya-Botero P, Martinez F, Rodriguez-Purata J, Rodriguez I, Coroleu B, Polyzos NP. The effect of type of oral contraceptive pill and duration of use on fresh and cumulative live birth rates in IVF/ICSI cycles. Hum Reprod. 2020 Apr 28;35(4):826-836. doi: 10.1093/humrep/dez299.
- Background: PubMed 38845190Racca A, Rodriguez I, Garcia S, Arroyo G, Polyzos NP. Double versus single stimulation in young low prognosis patients followed by a fresh embryo transfer: a randomized controlled trial (DUOSTIM-fresh). Hum Reprod. 2024 Jun 6:deae104. doi: 10.1093/humrep/deae104. Online ahead of print.
- Background: PubMed 9563682Veiga A, Sandalinas M, Benkhalifa M, Boada M, Carrera M, Santalo J, Barri PN, Menezo Y. Laser blastocyst biopsy for preimplantation diagnosis in the human. Zygote. 1997 Nov;5(4):351-4. doi: 10.1017/s0967199400003920.
- Background: PubMed 32416978Witz CA, Daftary GS, Doody KJ, Park JK, Seifu Y, Yankov VI, Heiser PW; Menopur in GnRH Antagonist Cycles with Single Embryo Transfer - High Responder (MEGASET-HR) Trial Group. Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection. Fertil Steril. 2020 Aug;114(2):321-330. doi: 10.1016/j.fertnstert.2020.03.029. Epub 2020 May 13.
- Background: PubMed 17640944Ziebe S, Lundin K, Janssens R, Helmgaard L, Arce JC; MERIT (Menotrophin vs Recombinant FSH in vitro Fertilisation Trial) Group. Influence of ovarian stimulation with HP-hMG or recombinant FSH on embryo quality parameters in patients undergoing IVF. Hum Reprod. 2007 Sep;22(9):2404-13. doi: 10.1093/humrep/dem221. Epub 2007 Jul 19.
- Background: PubMed 16873892Andersen AN, Devroey P, Arce JC. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Hum Reprod. 2006 Dec;21(12):3217-27. doi: 10.1093/humrep/del284. Epub 2006 Jul 27.
- Background: PubMed 9604764Boada M, Carrera M, De La Iglesia C, Sandalinas M, Barri PN, Veiga A. Successful use of a laser for human embryo biopsy in preimplantation genetic diagnosis: report of two cases. J Assist Reprod Genet. 1998 May;15(5):302-7. doi: 10.1023/a:1022548612107.
- Background: PubMed 33118716Chapon RCB, Genro VK, Souza CAB, Cunha-Filho JS. Randomized controlled trial comparing embryonic quality in rFSH versus hMG in the IVF protocol with GnRH Antagonist. JBRA Assist Reprod. 2021 Feb 2;25(1):131-135. doi: 10.5935/1518-0557.20200064.
- Background: PubMed 34154604Conforti A, Esteves SC, Humaidan P, Longobardi S, D'Hooghe T, Orvieto R, Vaiarelli A, Cimadomo D, Rienzi L, Ubaldi FM, Zullo F, Alviggi C. Recombinant human luteinizing hormone co-treatment in ovarian stimulation for assisted reproductive technology in women of advanced reproductive age: a systematic review and meta-analysis of randomized controlled trials. Reprod Biol Endocrinol. 2021 Jun 21;19(1):91. doi: 10.1186/s12958-021-00759-4.
- Background: PubMed 12909504Filicori M, Cognigni GE, Pocognoli P, Tabarelli C, Ferlini F, Perri T, Parmegiani L. Comparison of controlled ovarian stimulation with human menopausal gonadotropin or recombinant follicle-stimulating hormone. Fertil Steril. 2003 Aug;80(2):390-7. doi: 10.1016/s0015-0282(03)00594-6.
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- 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.
Nikolaos P Polyzos, MD, PhD principal investigator
Dexeus Universitary Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 10 mcg of follitropin-delta + 150 of hMG and 5 mcg of follitropin-delta + 225 of hMG in people with Infertility, run by Fundacion Dexeus at 4 sites 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 8 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: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Ignacio Rodriguez, MSc (0034932274700 ext. 22029, nacrod@dexeus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good quality blastocysts (time frame: From Day 5 to Day 7 after insemination). 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 NCT07691073, which also lists 11 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 Jul 2026.