By InvitationNot Applicable

Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate in PCOS Women With Glucose Metabolism Disorder Via IVF/ICSI

China254 participantsStarted 2024-11-01

Plain-language summary

Investigate the effect and mechanism of time-restricted eating (TRE) on the clinical pregnancy rate in women with PCOS and glucose metabolism disorder via IVF/ ICSI.

Who can participate

Age range

20 Years – 38 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

. Diagnosed with PCOS based on Rotterdam 2003 (all 3 criteria should be fulfilled);
. Diagnosed with glucose metabolism disorder (IGT, IFG, IGT with IFG, T2DM) and HbA1c less than or equal to 7%;
. Age 20-38;
. Overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2);
. Indication for IVF/ ICSI (repeated ovarian stimulation failure/ Fallopian tube blockage/ male factor) and ready for the 1st/ 2nd cycle of IVF;
. Cooperative to follow-ups and capable of reporting severe adverse event (SAE);
. Completed informed consent.

Exclusion criteria

. Unilateral ovary resection;
. Abnormal uterus cavity (congenital, chronic endometrium inflammation, polyps, adhesion, fibroids, etc);
. Chromosomal abnormality (either maternal or paternal);
. Recurrent abortion or recurrent failure of embryo transfer;

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

Clinical pregnancy rate for the first embryo transfer

Timeframe: 4-5 weeks after the IVF/ ICSI carried out at the end of the 6 weeks intervention

Trial details

NCT IDNCT06666933

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

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