PErsonalized Addition of Recombinant LH in Ovarian Stimulation (NCT04719000) | Clinical Trial Compass
RecruitingPhase 4
PErsonalized Addition of Recombinant LH in Ovarian Stimulation
Spain120 participantsStarted 2021-02-04
Plain-language 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.
Who can participate
Age range
35 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Geneti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum progesterone levels on the day of ovulation triggering.
Timeframe: 5 -20 days from initiation of ovarian stimulation
2
P/E2 ratio
Timeframe: 5 -20 days from initiation of ovarian stimulation