Personalized addition of LH in ovarian stimulation for infertility treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Universitario Quiron Dexeus
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Nikolaos P Polyzos, MD PhD
• Email: nikpol@dexeus.com
• Phone: 0034932274700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.