NCT04719000 PErsonalized Addition of Recombinant LH in Ovarian Stimulation
| NCT ID | NCT04719000 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fundación Santiago Dexeus Font |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-02-04 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2021-02-04 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Nikolaos P Polyzos, MD PhD
STUDY CHAIR
Hospital Universitari Dexeus
Frequently Asked Questions
Who can join the NCT04719000 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 40 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04719000 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04719000 currently recruiting?
Yes, NCT04719000 is actively recruiting participants. Contact the research team at nikpol@dexeus.com for enrollment information.
Where is the NCT04719000 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT04719000 clinical trial?
NCT04719000 is sponsored by Fundación Santiago Dexeus Font. The principal investigator is Nikolaos P Polyzos, MD PhD at Hospital Universitari Dexeus. The trial plans to enroll 120 participants.