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

Shanghai Jiao Tong University

Status: Invitation-only

Conditions: PCOS; IVF Outcome; Glucose Metabolism Disorder

Treatments: Drug: Metformin; Behavioral: Time restricted eating

Study type: Interventional

Funder types: Other

Identifiers

NCT06666933

LY2024-160

Details and patient eligibility

About

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.

Full description

In this multicenter randomized controlled study, investigators plan to recruit 254 patients, aged 20-38, with PCOS and glucose metabolism disorder. PCOS diagnostic criteria based on Rotterdam 2003 criteria, glucose metabolism disorder are diagnosed by 1998 WHO diagnostic criteria, with HbA1c≤7%. Participants selected are overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2), and are planned to start the 1st/ 2nd cycle of IVF/ ICSI.

Investigators divide these patients randomly into 2 groups (each group with 127 patients): metformin only group (control group) and TRE with metformin group. Every participant receives the specific treatment according to the group for at least 6 weeks. During the intervention period, follow-ups, blood chemistry tests and examinations are recorded every 2 weeks. After the intervention period, IVF/ ICSI is carried out. GnRH-agonist- or/and hCG-triggered is used for ovarian stimulation. Ovum retrieval will be carried out 34-36h after ovarian stimulation. Blood hCG is tested after 12-14 days after embryonic transfer. For patients with positive hCG, clinical pregnancy is confirmed by observing gestational sac via transvaginal ultrasound after 4-5 weeks.

Investigators compare the terminal pregnancy-related result and metabolic changes between 2 groups to determine the effect and the possible mechanisms of TRE on IVF/ ICSI clinical pregnancy rate of PCOS with glucose metabolism disorder patients.

Enrollment: 254 estimated patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Unilateral ovary resection;
2. Abnormal uterus cavity (congenital, chronic endometrium inflammation, polyps, adhesion, fibroids, etc);
3. Chromosomal abnormality (either maternal or paternal);
4. Recurrent abortion or recurrent failure of embryo transfer;
5. Metformin allergy/ intolerance;
6. Other serious or uncontrolled diseases (e.g. kidney insufficiency, infection, controlled hypertension, heart disease, etc);
7. Preimplantation genetic testing;
8. Other condition that may impact the results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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254 participants in 2 patient groups

Time restricted eating with metformin

Experimental group

Description:

TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks

Treatment:

Behavioral: Time restricted eating

Drug: Metformin

Metformin only

Other group

Description:

Taking metformin 1g bid po for 6 weeks only

Treatment:

Drug: Metformin