Actively Recruiting
PErsonalized Addition of Recombinant LH in Ovarian Stimulation
Led by Fundación Santiago Dexeus Font · Updated on 2026-03-30
120
Participants Needed
1
Research Sites
351 weeks
Total Duration
On this page
Sponsors
F
Fundación Santiago Dexeus Font
Lead Sponsor
M
Merck, S.L., Spain
Collaborating Sponsor
AI-Summary
What this Trial Is About
Different ovarian stimulation regimens have shown to modify late follicular phase hormonal profiles. Besides, recent studies confirm that progesterone levels and their variation in the last day of oocyte maturation are affected by the dose of gonadotropins administered and by other factors. Progesterone elevation in late follicular phase of in vitro fertilization/intracytoplasmatic sperm injection (IVF/ICSI) cycles under ovarian stimulation compromises implantation rates due to a negative effect on the endometrium. However, there is still conflict in the literature questioning whether progesterone levels alone on the triggering day is a sufficient indicator as progesterone does not give the full picture of the ovarian functions, number of follicles as well as estrogen production that facilitate endometrial growth, thus some studies suggest that especially in aged and poor responders Progesterone/Estrogen (P4/E2) ratio has a better reflection (Progesterone (ng/mL) ×1,000/estradiol(pg/mL)) on the ovarian function. The scope of the current pilot study is to compare serum progesterone levels as well as P4/E2 ratio on the day of ovulation triggering of women belonging to POSEIDON category group 2 who undergo a new ovarian stimulation with a dose of rhFSH 300 IU or 300 IU rhFSH plus 150 IU recombinant human luteinizing hormone (rhLH) in a gonadotropin-releasing hormone (GnRH) antagonist protocol.
CONDITIONS
Official Title
PErsonalized Addition of Recombinant LH in Ovarian Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to sign the Patient Consent Form and follow the study visit schedule
- Female aged 35 to 40 years old
- Antral follicle count (AFC) of 5 or more and/or anti-Müllerian hormone (AMH) level of at least 1.2 ng/mL
- Fewer than 4 or 4 to 9 oocytes retrieved in a previous IVF/ICSI cycle starting with 225 IU or less of gonadotropin under a GnRH antagonist protocol
- Up to 3 previous ovarian stimulation cycles with starting doses of 225 IU or less and dose adjustments not exceeding 300 IU
- Undergoing ovarian stimulation for IVF/ICSI
You will not qualify if you...
- Poor ovarian responders based on Bologna criteria
- Polycystic ovary syndrome (PCOS) according to Rotterdam criteria
- Antral follicle count (AFC) greater than 20
- Age younger than 35 or older than 40 years
- More than 10 oocytes retrieved in a previous IVF/ICSI cycle with 150-225 IU starting dose
- Previous dose adjustments during stimulation exceeding 300 IU
- Uterine abnormalities
- Current untreated endocrine disorders
- Unilateral or bilateral hydrosalpinx visible on ultrasound unless surgically clipped
- Contraindications to ovarian stimulation medications (gonadotropins, GnRH antagonist, progesterone vaginal gel)
- Recent severe disease requiring regular treatment or contraindications to pregnancy
- Undergoing Preimplantation Genetic Testing for Aneuploidies (PGT-a)
- Use of Testicular Sperm Aspiration or Extraction (TESA or TESE)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario Quiron Dexeus
Barcelona, Spain, 08028
Actively Recruiting
Research Team
N
Nikolaos P Polyzos, MD PhD
CONTACT
I
Ignacio Rodríguez, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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