Glucose Metabolism Disorder, IVF Outcome, PCOS
Conditions
Keywords
PCOS, Glucose Metabolism Disorder, IVF, ICSI, time-restricted eating
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.
Interventions
BEHAVIORALTime restricted eating
TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks
DRUGMetformin
Taking metformin 1g bid po only for 6 weeks as control
Sponsors
Guangdong Provincial People's Hospital
Shanghai First Maternity and Infant Hospital
First Affiliated Hospital of Wenzhou Medical University
Shengjing Hospital
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Weight | From enrollment to the end of treatment at 6 weeks | Weight change in kg |
| Fat% | From enrollment to the end of treatment at 6 weeks | Inbody machine measurement |
| 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 |
| 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 |
| Lipid profile | From enrollment to the end of treatment at 6 weeks | Triglycerol, total cholesterol, HDL, LDL, free fatty acid in mmol/L |
Countries
China
Outcome results
None listed