Embryo QUAlity in Ovarian Stimulation With hMG.
ConditionInfertility
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age38-41
SponsorFundacion Dexeus
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
10 mcg of follitropin-delta + 150 of hMG
DrugOn 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 hMG
DrugOn 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: 10 mcg of Rekovelle + 150 IU of MenopurExperimental treatment 1 intervention
Group B: 5 mcg of Rekovelle + 225 IU of MenopurActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Good quality blastocysts
number of good quality blastocysts based on the Istanbul consensus workshop criteria
Time frame
From Day 5 to Day 7 after inseminationSecondary outcomes
1
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)2
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)3
Total Number of Oocytes Retrieved
Total number of oocytes collected during oocyte retrieval procedure following ovarian stimulation.
Time frame
At oocyte retrieval4
Number of mature oocytes (MII) retrieved
Number of metaphase II (MII) oocytes identified among retrieved oocytes
Time frame
At oocyte retrievalSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundacion Dexeus
Lead sponsor
Ferring Pharmaceuticals
Collaborator
Source ClinicalTrials.gov
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