A Phase 4 interventional study of 10 mcg of follitropin-delta + 150 of hMG and 5 mcg of follitropin-delta + 225 of hMG in Infertility, sponsored by Fundacion Dexeus. Not yet recruiting at 4 sites in Spain. Open to female participants aged 38 Years to 41 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Fundacion Dexeus · Phase 4, Interventional, and Treatment
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 240 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Fundacion Dexeus is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 10 mcg of follitropin-delta + 150 of hMG
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.
Drug: 5 mcg of follitropin-delta + 225 of hMG
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.
Good quality blastocysts
number of good quality blastocysts based on the Istanbul consensus workshop criteria
Time frame: From Day 5 to Day 7 after insemination
Total Gonadotropin Dose Administered
Cumulative dose of gonadotropins (IU) administered during ovarian stimulation.
Time frame: 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.
Time frame: 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.
Time frame: At oocyte retrieval
Number of mature oocytes (MII) retrieved
Number of metaphase II (MII) oocytes identified among retrieved oocytes
Time frame: At oocyte retrieval
Serum levels of estradiol (E2)
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 of progesterone (P4)
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 of follicle-stimulating hormone (FSH)
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 of luteinizing hormone (LH)
Serum levels luteinizing hormone (LH) 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)
Follicle-to-Oocyte Index (FOI)
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 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.
Time frame: From baseline AFC assessment to trigger day
Cycle cancellation rate
Proportion of initiated ovarian stimulation cycles that are cancelled before oocyte retrieval.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Within 0-6 hours post-ICSI/insemination
Time of pronuclei appearance (tPNa)
Time from insemination or ICSI to the first visualization of pronuclei.
Time frame: Within 0-20 hours post-ICSI/insemination
Evaluation of both pronuclei
Time from insemination or ICSI to the visualization of both pronuclei.
Time frame: Within 0-20 hours post-ICSI/insemination
Time to Pronuclear Fading (tPNf)
Time from insemination or ICSI to disappearance of pronuclei
Time frame: 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
Time frame: From fertilization to Day 3 (up to 72 hours)
Time of compaction (tSC)
Time from fertilization to the beginning of blastomere compaction.
Time frame: 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.
Time frame: Day 4 post-fertilization (up to 120 hours)
Time of cavitation (tSB)
Time from fertilization to the initiation of blastocoel cavity formation.
Time frame: 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.
Time frame: 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.
Time frame: Day 5 post-fertilization
Total number of Day 6 blastocysts
Number of embryos reaching the blastocyst stage by Day 6 of development.
Time frame: Day 5 post-fertilization
Total number of Day 7 blastocysts
Number of embryos reaching the blastocyst stage by Day 7 of development.
Time frame: Day 5 post-fertilization
Total number of euploid embryos
Number of embryos identified as chromosomally normal following preimplantation genetic testing (PGT-A)
Time frame: 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.
Time frame: From oocyte retrieval to blastocyst stage (up to Day 5-7)
Number of embryos cryopreserved
Total number of embryos suitable for vitrification following culture.
Time frame: At end of embryo culture (Day 5-7)
Clinical pregnancy rate
Presence of one or more intrauterine gestational sacs confirmed by ultrasound.
Time frame: 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.
Time frame: At 8-10 weeks of gestation
Miscarriage Rate
Proportion of clinical pregnancies that result in spontaneous pregnancy loss before 20 weeks of gestation.
Time frame: 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.
Time frame: At delivery (up to ~40 weeks of gestation following embryo transfer)
Plan to share: Undecided
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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