CompletedPhase 4

Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial

Italy110 participantsStarted 2022-02-22

Plain-language summary

The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone \> 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.

Who can participate

Age range

25 Years – 42 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: * Indication to IVF treatment * Normal BMI (18.5-24.9 kg/m2) * AMH level \< 1.1 ng/ml and/or AFC \< 5 follicles and/or \< 3 oo-cytes retrieved in previous cycle * Regular menstrual cycles * Signed informed consent Exclusion Criteria: * Freeze all cycles for abnormal bleeding * PCOS * History of untreated autoimmune * Endocrine or metabolic disorders * Ovarian cystectomy or oophorectomy * FSH ≥ 20 lU/L

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

Premature progesterone elevation

Timeframe: day 12

Trial details

NCT IDNCT04695483

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-19

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