PErsonalized Addition of Recombinant LH in Suboptimal Responders >35 Years Old (POSEIDON Group 2): A Randomized Controlled Trial

FSD-RHLH-2019-08

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.

2021-02-04

2025-08-01

2025-11-01

Recruiting

Early phase I

120

Inclusion Criteria: * Able and willing to sign the Patient Consent Form and adhere to study visitation schedule. * ≥ 35 years ≤40 years old. * AFC ≥5 and or AMH ≥1.2 ng/mL. * \<4 or 4-9 oocytes retrieved in a previous IVF/ICSI cycle with a starting dose of ≤225 IU with any gonadotropin under a GnRH antagonist protocol. * Up to 3 previous ovarian stimulation cycles with a starting dose of ≤225 IU in which dose adjustments during stimulation did not exceed 300 IU. * Ovarian stimulation for IVF/ICSI Exclusion Criteria: * Poor ovarian responders according to the Bologna criteria. * Polycystic ovary syndrome (PCOS) patients according to the Rotterdam criteria. * AFC\>20. * Age \>40 or \<35 years old. * Women with \>10 oocytes retrieved in a previous IVF/ICSI cycle with 150-225 IU starting dose. * Women who required dose adjustments during stimulation \>300 IU with any gonadotropin in their previous cycle * Uterine abnormalities. * Recent history of any current untreated endocrine abnormality. * Unilateral or bilateral hydrosalpinx (visible on ultrasound scan (USS), unless clipped). * Contraindications for the use of medicine used for ovarian stimulation (gonadotropins, GnRH antagonist, progesterone vaginal gel) * Recent history of severe disease requiring regular treatment (Clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication to pregnancy). * Preimplantation Genetic Testing for Aneuploidies (PGT-a). * Testicular Sperm Aspiration or Testicular Sperm Extraction (TESA or TESE)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-05-22