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

NCT ID: NCT06666933

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-07-31

Brief 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.

Detailed 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.

Conditions

PCOS; Glucose Metabolism Disorder; IVF Outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Time restricted eating with metformin

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

Group Type: EXPERIMENTAL

Time restricted eating

Intervention Type: BEHAVIORAL

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

Metformin

Intervention Type: DRUG

Taking metformin 1g bid po only for 6 weeks as control

Metformin only

Taking metformin 1g bid po for 6 weeks only

Group Type: OTHER

Metformin

Intervention Type: DRUG

Taking metformin 1g bid po only for 6 weeks as control

Interventions

Time restricted eating

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

Intervention Type: BEHAVIORAL

Metformin

Taking metformin 1g bid po only for 6 weeks as control

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Shengjing Hospital

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Tao, MD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital Department of Endocrinology and Metabolism

Locations

RenJi Hospital Department of Endocrinology and Metabolism

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

LY2024-160

Identifier Type: -

Identifier Source: org_study_id