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RECRUITING
NCT04719000
PHASE4

PErsonalized Addition of Recombinant LH in Ovarian Stimulation

Sponsor: Fundación Santiago Dexeus Font

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

35 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-02-04

Completion Date

2027-11

Last Updated

2026-03-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

rhFSH+rhLH

300 IU of rhFSH and 150 IU of rhLH (Pergoveris®) GnRH antagonist: cetrorelix 0.25 mg (Cetrotide® - Merck) GnRH antagonist: cetrorelix 0.25 mg (Cetrotide® - Merck) Recombinant human chorionic gonadotropin (rhCG) 6500 IU (Ovitrelle® - Merck) micronized progesterone 90 mg (Crinone 8% ® - Merck)

DRUG

rhFSH

300 IU rhFSH (Gonal-F®- Merck) GnRH antagonist: cetrorelix 0.25 mg (Cetrotide® - Merck) GnRH antagonist: cetrorelix 0.25 mg (Cetrotide® - Merck) rhCG 6500 IU (Ovitrelle® - Merck) micronized progesterone 90 mg (Crinone 8% ® - Merck)

Locations (1)

Hospital Universitario Quiron Dexeus

Barcelona, Spain