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NCT07691073
Embryo QUAlity in Ovarian Stimulation With hMG.
Conditions: Infertility
Sex: Female
Ages: 38 Years – 41 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 240
Sponsor: Fundacion Dexeus
Location: Dexeus Mujer Sabadell Sabadell Barcelona
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. 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
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07691073). StuddyBuddy aggregates publicly available trial information.