Personalized addition of LH in ovarian stimulation for infertility treatment

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

This study is testing if adding a hormone called LH to the usual fertility treatment can help women aged 35 to 40 have better chances of getting pregnant through IVF.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 35 Years to 40 Years
• Sex: Female
• Sponsor: Fundacion Dexeus (other)
• Locations: 1 site (Barcelona)
• Trial ID: NCT04719000 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of adding recombinant LH to ovarian stimulation regimens in women undergoing IVF/ICSI. The study aims to optimize hormonal profiles during the late follicular phase to improve implantation rates by analyzing the progesterone/estrogen ratio. Participants will be women aged 35 to 40 with specific ovarian response criteria, and the trial will compare outcomes between those receiving rhFSH alone and those receiving a combination of rhFSH and rhLH. The goal is to enhance the success rates of assisted reproductive technology by tailoring hormonal treatments based on individual responses.

Who should consider this trial

Good fit: Ideal candidates are women aged 35 to 40 with a moderate ovarian reserve and a history of limited oocyte retrieval in previous IVF/ICSI cycles.

Not a fit: Patients who are poor responders according to Bologna criteria or those with PCOS may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved pregnancy rates for women undergoing IVF/ICSI by optimizing hormonal conditions.

How similar studies have performed: Other studies have shown varying success with similar hormonal optimization approaches, but this specific combination is relatively novel.

Eligibility criteria

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)

Where this trial is running

Barcelona

• Hospital Universitario Quiron Dexeus — Barcelona, Spain (RECRUITING)

Study contacts

• Study coordinator: Nikolaos P Polyzos, MD PhD

Conditions: Infertility