NCT Number: NCT07691073
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.
Trial opening soon.
Get Notified38 year–41 year
Female
Interventional
Phase 4
Dexeus Mujer Sabadell, Sabadell, Barcelona, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From Day 5 to Day 7 after insemination
number of good quality blastocysts based on the Istanbul consensus workshop criteria
Time frame: From initiation of ovarian stimulation until day of trigger (up to 15 days)
Cumulative dose of gonadotropins (IU) administered during ovarian stimulation.
Time frame: From first day of stimulation until trigger day (up to 15days)
Number of days of gonadotropin administration required to reach criteria for triggering final oocyte maturation.
Time frame: At oocyte retrieval
Total number of oocytes collected during oocyte retrieval procedure following ovarian stimulation.
Time frame: At oocyte retrieval
Number of metaphase II (MII) oocytes identified among retrieved oocytes
Time frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of estradiol (E2) measured at predefined time points during stimulation
Time frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels progesterone (P4) measured at predefined time points during stimulation
Time frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels follicle-stimulating hormone (FSH) measured at predefined time points during stimulation
Time frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels luteinizing hormone (LH) measured at predefined time points during stimulation
Time frame: From baseline AFC assessment to oocyte retrieval
Ratio between the total number of oocytes retrieved and the number of antral follicles counted at baseline before stimulation.
Time frame: From baseline AFC assessment to trigger day
Ratio between the number of preovulatory follicles on the day of trigger and the number of antral follicles at baseline.
Time frame: From start of stimulation to planned oocyte retrieval
Proportion of initiated ovarian stimulation cycles that are cancelled before oocyte retrieval.
Time frame: At time of 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).
Time frame: Assessed 16-20 hours post-insemination or ICSI
Proportion of oocytes that are successfully fertilized (2PN) relative to the number of inseminated or injected (ICSI) oocytes.
Time frame: Within 0-6 hours post-ICSI/insemination
ime from insemination or ICSI to the extrusion of the second polar body, indicating completion of oocyte activation.
Time frame: Within 0-20 hours post-ICSI/insemination
Time from insemination or ICSI to the first visualization of pronuclei.
Time frame: Within 0-20 hours post-ICSI/insemination
Time from insemination or ICSI to the visualization of both pronuclei.
Time frame: Within 20-30 hours post-ICSI/insemination
Time from insemination or ICSI to disappearance of pronuclei
Time frame: From fertilization to Day 3 (up to 72 hours)
Time to reach each embryonic cell stage from 2 to 8 cells
Time frame: Day 3-4 post-fertilization (up to ~96 hours)
Time from fertilization to the beginning of blastomere compaction.
Time frame: Day 4 post-fertilization (up to 120 hours)
Time from fertilization to the formation of a compact morula stage embryo.
Time frame: Day 4-5 post-fertilization (up to ~120-132 hours)
Time from fertilization to the initiation of blastocoel cavity formation.
Time frame: Day 5-6 post-fertilization (up to ~144 hours)
Time from fertilization to formation of a fully expanded blastocyst.
Time frame: Day 5 post-fertilization
Number of embryos reaching the blastocyst stage by Day 5 of development.
Time frame: Day 5 post-fertilization
Number of embryos reaching the blastocyst stage by Day 6 of development.
Time frame: Day 5 post-fertilization
Number of embryos reaching the blastocyst stage by Day 7 of development.
Time frame: After genetic testing results (typically within 1-2 weeks post-biopsy)
Number of embryos identified as chromosomally normal following preimplantation genetic testing (PGT-A)
Time frame: From oocyte retrieval to blastocyst stage (up to Day 5-7)
Proportion of mature (MII) oocytes that develop into blastocysts.
Time frame: At end of embryo culture (Day 5-7)
Total number of embryos suitable for vitrification following culture.
Time frame: At 5-7 weeks of gestation
Presence of one or more intrauterine gestational sacs confirmed by ultrasound.
Time frame: At 8-10 weeks of gestation
Proportion of pregnancies with a viable intrauterine fetus beyond 8-10 weeks of gestation confirmed by ultrasound.
Time frame: From confirmation of clinical pregnancy up to 20 weeks of gestation
Proportion of clinical pregnancies that result in spontaneous pregnancy loss before 20 weeks of gestation.
Time frame: At delivery (up to ~40 weeks of gestation following embryo transfer)
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.
Contact information is provided by the study sponsor or research team.
Fundacion Dexeus
Other
The Impact of Ovarian Stimulation With hMG on Embryo Quality in Advanced Age Women. A Randomized Controlled Trial
Acronym: EQUAM
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