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

Not Applicable

• Conditions: PCOS; Glucose Metabolism Disorder; IVF Outcome
• Interventions: Behavioral: Time restricted eating; Drug: Metformin

• Registration Number: NCT06666933
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-20
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31
• Study Start: 2024-11-01
• Primary Completion: 2025-11
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 254

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time restricted eating with metformin	Time restricted eating	TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks
Time restricted eating with metformin	Metformin	TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks
Metformin only	Metformin	Taking metformin 1g bid po for 6 weeks only

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate for the first embryo transfer	4-5 weeks after the IVF/ ICSI carried out at the end of the 6 weeks intervention	Clinical pregnancy rate= (number of cycle for 1or more gestational sac is observed via transvaginal ultrasound/ total number of cycle for first embryo transfer)x100%

Secondary Outcome Measures

Name	Time	Method
Lipid profile	From enrollment to the end of treatment at 6 weeks	Triglycerol, total cholesterol, HDL, LDL, free fatty acid in mmol/L
Blood pressure	From enrollment to the end of treatment at 6 weeks	Both systolic and diastolic pressure in mmHg
Sex hormone	From enrollment to the end of treatment at 6 weeks	DHEAs, testosterone, androstadienone, estradiol, LH, FSH, progesterone, prolactin, SHBG
OGTT	From enrollment to the end of treatment at 6 weeks	Blood glucose level at 0h, 1h, 2h in mmol/L
Insulin stimulation	From enrollment to the end of treatment at 6 weeks	Serum insulin level at 0h, 1h, 2h in ng/ml
Fat%	From enrollment to the end of treatment at 6 weeks	Inbody machine measurement
Number of good quality embryo	After the IVF/ ICSI carried out at the end of the 6 weeks intervention	Day 3 embryo with 7-9 cells and \<10% fragmentation
Number of retrieved oocytes	After the IVF/ ICSI carried out at the end of the 6 weeks intervention	Includes immature oocytes, mature oocytes and abnormal oocytes from ovum pick-up
Implantation rate	After the IVF/ ICSI carried out at the end of the 6 weeks intervention	the ration of total number of early gestational sacs to total number of transferred embryos
Abortion rate	After the IVF/ ICSI carried out at the end of the 6 weeks intervention	the ratio of the number of nonviable pregnancies before 28 weeks of gestation to the number of clinical pregnancies
Weight	From enrollment to the end of treatment at 6 weeks	Weight change in kg

Trial Locations

Locations (1)

RenJi Hospital Department of Endocrinology and Metabolism; 🇨🇳 Shanghai, Shanghai, China