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

Who is this study for? Patients with Infertility
What treatments are being studied? rhFSH
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 35
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Universitario Quiron Dexeus
RECRUITING
Barcelona
Contact Information
Primary
Nikolaos P Polyzos, MD PhD
nikpol@dexeus.com
0034932274700
Backup
Ignacio Rodríguez, MSc
nacrod@dexeus.com
0034932274700
Time Frame
Start Date: 2021-02-04
Estimated Completion Date: 2025-11
Participants
Target number of participants: 120
Treatments
Experimental: rhFSH+rhLH
Ovarian Stimulation with rhFSH+rhLH
Active_comparator: rhFSH
Ovarian Stimulation with rhFSH
Authors
Iñaki González Foruria
Related Therapeutic Areas
Sponsors
Leads: Fundación Santiago Dexeus Font
Collaborators: Merck, S.L., Spain

This content was sourced from clinicaltrials.gov

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