PCOSNCT06666933
Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate in PCOS Women With Glucose Metabolism Disorder Via IVF/ICSI
A study testing Time restricted eating and Metformin in people with PCOS and Glucose Metabolism Disorder, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- PCOS, Glucose Metabolism Disorder, IVF Outcome
- What is being tested?
- Time restricted eating and Metformin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with PCOS based on Rotterdam 2003 (all 3 criteria should be fulfilled);
- Diagnosed with glucose metabolism disorder (IGT, IFG, IGT with IFG, T2DM) and HbA1c less than or equal to 7%;
- Age 20-38;
- Overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2);
- Indication for IVF/ ICSI (repeated ovarian stimulation failure/ Fallopian tube blockage/ male factor) and ready for the 1st/ 2nd cycle of IVF;
- Cooperative to follow-ups and capable of reporting severe adverse event (SAE);
- Completed informed consent.
Who cannot join
- Unilateral ovary resection;
- Abnormal uterus cavity (congenital, chronic endometrium inflammation, polyps, adhesion, fibroids, etc);
- Chromosomal abnormality (either maternal or paternal);
- Recurrent abortion or recurrent failure of embryo transfer;
- Metformin allergy/ intolerance;
- Other serious or uncontrolled diseases (e.g. kidney insufficiency, infection, controlled hypertension, heart disease, etc);
- Preimplantation genetic testing;
- Other condition that may impact the results
Trial locations and contacts
1 site in 1 country.
China1 site
RenJi Hospital Department of Endocrinology and Metabolism
Shanghai, Shanghai Municipality, 200127
About this study
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)
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.
Read the 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
- Being tested
- Time restricted eating, Metformin
- Keywords
- PCOS, Glucose Metabolism Disorder, IVF, ICSI, time-restricted eating
- Medical subject headings
- Glucose Metabolism Disorders, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks
MetforminDrug
Taking metformin 1g bid po only for 6 weeks as control
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Time restricted eating; Drug: Metformin |
| Metformin only | Other | Taking metformin 1g bid po for 6 weeks only Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 4-5 weeks after the IVF/ ICSI carried out at the end of the 6 weeks intervention
Secondary outcomes (11)
Number of retrieved oocytes
Includes immature oocytes, mature oocytes and abnormal oocytes from ovum pick-up
Measured: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
Implantation rate
the ration of total number of early gestational sacs to total number of transferred embryos
Measured: 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
Measured: 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
Measured: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
Weight
Weight change in kg
Measured: From enrollment to the end of treatment at 6 weeks
Fat%
Inbody machine measurement
Measured: From enrollment to the end of treatment at 6 weeks
Lipid profile
Triglycerol, total cholesterol, HDL, LDL, free fatty acid in mmol/L
Measured: From enrollment to the end of treatment at 6 weeks
Blood pressure
Both systolic and diastolic pressure in mmHg
Measured: From enrollment to the end of treatment at 6 weeks
Sex hormone
DHEAs, testosterone, androstadienone, estradiol, LH, FSH, progesterone, prolactin, SHBG
Measured: From enrollment to the end of treatment at 6 weeks
OGTT
Blood glucose level at 0h, 1h, 2h in mmol/L
Measured: From enrollment to the end of treatment at 6 weeks
Insulin stimulation
Serum insulin level at 0h, 1h, 2h in ng/ml
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Shanghai First Maternity and Infant Hospital, First Affiliated Hospital of Wenzhou Medical University, Shengjing Hospital
- Responsible party
- Sponsor
- Investigators
- Tao Tao, MD, Principal investigator, RenJi Hospital Department of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666933
- Sponsor's protocol ID
- LY2024-160
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06666933
- Acronym / sponsor ID
- LY2024-160
- Conditions
- PCOS, Glucose Metabolism Disorder, IVF Outcome
- Keywords
- PCOS, Glucose Metabolism Disorder, IVF, ICSI, time-restricted eating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Shanghai First Maternity and Infant Hospital, First Affiliated Hospital of Wenzhou Medical University, Shengjing Hospital
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating with metformin | Experimental | Behavioral: Time restricted eating, Drug: MetforminTRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks |
| Metformin only | Other | Drug: MetforminTaking metformin 1g bid po for 6 weeks only |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosed with PCOS based on Rotterdam 2003 (all 3 criteria should be fulfilled);
- Diagnosed with glucose metabolism disorder (IGT, IFG, IGT with IFG, T2DM) and HbA1c less than or equal to 7%;
- Age 20-38;
- Overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2);
- Indication for IVF/ ICSI (repeated ovarian stimulation failure/ Fallopian tube blockage/ male factor) and ready for the 1st/ 2nd cycle of IVF;
Key exclusion criteria (8 listed)
- Unilateral ovary resection;
- Abnormal uterus cavity (congenital, chronic endometrium inflammation, polyps, adhesion, fibroids, etc);
- Chromosomal abnormality (either maternal or paternal);
- Recurrent abortion or recurrent failure of embryo transfer;
- Metformin allergy/ intolerance;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eatingTRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks | Behavioural | Time restricted eating with metformin |
| MetforminTaking metformin 1g bid po only for 6 weeks as control | Drug | Metformin only, Time restricted eating with metformin |
Primary outcome
Clinical pregnancy rate for the first embryo transfer
Time frame: 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%
11 secondary outcomes
Number of retrieved oocytes
Time frame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
Implantation rate
Time frame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
Abortion rate
Time frame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
Number of good quality embryo
Time frame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
Weight
Time frame: From enrollment to the end of treatment at 6 weeks
Fat%
Time frame: From enrollment to the end of treatment at 6 weeks
Lipid profile
Time frame: From enrollment to the end of treatment at 6 weeks
Blood pressure
Time frame: From enrollment to the end of treatment at 6 weeks
Sex hormone
Time frame: From enrollment to the end of treatment at 6 weeks
OGTT
Time frame: From enrollment to the end of treatment at 6 weeks
Insulin stimulation
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Tao, MD principal investigator
RenJi Hospital Department of Endocrinology and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating and Metformin in people with PCOS and Glucose Metabolism Disorder, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate for the first embryo transfer (time frame: 4-5 weeks after the IVF/ ICSI carried out at the end of the 6 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.