About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
rhFSH+rhLH
Drug300 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)
rhFSH
Drug300 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)
Treatment groups
Trial outcomes
Primary outcomes
Serum progesterone levels on the day of ovulation triggering.
The outcome will be evaluated on the day of ovulation triggering
P/E2 ratio
Progesterone / estradiol ratio
Secondary outcomes
Progesterone Profile
Estradiol Profile
FSH Profile
Testosterone Profile
Other outcomes
Ovarian hyperstimulation syndrome (OHSS) (percent).
Number of subjects with OHSS during the ovarian stimulation period and their severity
Miscarriages
any spontaneous abortion that occurred after confirmation of clinical pregnancy
Cycle cancelation
when no follicle has adequate maturation or the follicle is lost due to spontaneous LH surge
Incidence of adverse events and serious adverse events
Sponsors and contacts
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Fundación Santiago Dexeus Font
Lead sponsor
Merck, S.L., Spain
Collaborator