Clinical trial NCT06666933: Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate in PCOS Women With Glucose Metabolism Disorder Via IVF/ICSI
Official title: Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate Via IVF/ICSI in Women With PCOS and Glucose Metabolism Disorder: A Multicenter Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: PCOS
Glucose Metabolism Disorder
IVF Outcome
Keywords: PCOS
Glucose Metabolism Disorder
IVF
ICSI
time-restricted eating
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: Shanghai First Maternity and Infant Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Shengjing Hospital
First posted: 2024-10-31
Enrollment: 254
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Number of retrieved oocytes
timeFrame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
measure: Implantation rate
timeFrame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
measure: Abortion rate
timeFrame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
measure: Number of good quality embryo
timeFrame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
measure: Weight
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Fat%
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Lipid profile
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Blood pressure
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Sex hormone
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: OGTT
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Insulin stimulation
timeFrame: From enrollment to the end of treatment at 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital Department of Endocrinology and Metabolism
state: Shanghai
Study officials:
affiliation: RenJi Hospital Department of Endocrinology and Metabolism
name: Tao Tao, MD
role: PRINCIPAL_INVESTIGATOR
References: