Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
| Shanghai First Maternity and Infant Hospital | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time restricted eating with metformin | Experimental | TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks |
|
| Metformin only | Other | Taking metformin 1g bid po for 6 weeks only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted eating | Behavioral | TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate for the first embryo transfer | 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% | 4-5 weeks after the IVF/ ICSI carried out at the end of the 6 weeks intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of retrieved oocytes | Includes immature oocytes, mature oocytes and abnormal oocytes from ovum pick-up | After the IVF/ ICSI carried out at the end of the 6 weeks intervention |
| Implantation rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tao Tao, MD | RenJi Hospital Department of Endocrinology and Metabolism | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital Department of Endocrinology and Metabolism | Shanghai | Shanghai Municipality | 200127 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Shengjing Hospital |
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Metformin | Drug | Taking metformin 1g bid po only for 6 weeks as control |
|
the ration of total number of early gestational sacs to total number of transferred embryos
| After the IVF/ ICSI carried out at the end of the 6 weeks intervention |
| Abortion rate | the ratio of the number of nonviable pregnancies before 28 weeks of gestation to the number of clinical pregnancies | After the IVF/ ICSI carried out at the end of the 6 weeks intervention |
| Number of good quality embryo | Day 3 embryo with 7-9 cells and <10% fragmentation | After the IVF/ ICSI carried out at the end of the 6 weeks intervention |
| Weight | Weight change in kg | From enrollment to the end of treatment at 6 weeks |
| Fat% | Inbody machine measurement | From enrollment to the end of treatment at 6 weeks |
| Lipid profile | Triglycerol, total cholesterol, HDL, LDL, free fatty acid in mmol/L | From enrollment to the end of treatment at 6 weeks |
| Blood pressure | Both systolic and diastolic pressure in mmHg | From enrollment to the end of treatment at 6 weeks |
| Sex hormone | DHEAs, testosterone, androstadienone, estradiol, LH, FSH, progesterone, prolactin, SHBG | From enrollment to the end of treatment at 6 weeks |
| OGTT | Blood glucose level at 0h, 1h, 2h in mmol/L | From enrollment to the end of treatment at 6 weeks |
| Insulin stimulation | Serum insulin level at 0h, 1h, 2h in ng/ml | From enrollment to the end of treatment at 6 weeks |
| D001519 |
| Behavior |