Embryo QUAlity in Ovarian Stimulation With hMG.

Sponsor
Fundacion Dexeus
Study ID
NCT07691073
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
38 Years - 41 Years
Healthy Volunteers
Not accepted

Interventions

  • 10 mcg of follitropin-delta + 150 of hMG — DRUG
    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 hMG — DRUG
    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 Details

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.

Key Dates

First listed
Jul 8, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2029
Completion
May 31, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 10 mcg of Rekovelle + 150 IU of Menopur
    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.
  • Active Comparator: 5 mcg of Rekovelle + 225 IU of Menopur
    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.

Primary Outcome Measure

Good quality blastocysts [ Time Frame: From Day 5 to Day 7 after insemination ]

Central Contacts

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