NCT06666933

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Nov 2024Jul 2026

First Submitted

Initial submission to the registry

October 20, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 20, 2024

Last Update Submit

October 28, 2024

Conditions

PCOSGlucose Metabolism DisorderIVF Outcome

Keywords

PCOSGlucose Metabolism DisorderIVFICSItime-restricted eating

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • Number of retrieved oocytes

    After the IVF/ ICSI carried out at the end of the 6 weeks intervention

  • Implantation rate

    After the IVF/ ICSI carried out at the end of the 6 weeks intervention

  • Abortion rate

    After the IVF/ ICSI carried out at the end of the 6 weeks intervention

  • Number of good quality embryo

    After the IVF/ ICSI carried out at the end of the 6 weeks intervention

  • Weight

    From enrollment to the end of treatment at 6 weeks

  • +6 more secondary outcomes

Study Arms (2)

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

Behavioral: Time restricted eatingDrug: Metformin

Metformin only

OTHER

Taking metformin 1g bid po for 6 weeks only

Drug: Metformin

Interventions

Time restricted eatingBEHAVIORAL

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
MetforminDRUG

Taking metformin 1g bid po only for 6 weeks as control

Metformin onlyTime restricted eating with metformin

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RenJi Hospital Department of Endocrinology and Metabolism

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Glucose Metabolism DisordersIntermittent Fasting

Interventions

Metformin

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesFastingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Tao Tao, MD

    RenJi Hospital Department of Endocrinology and Metabolism

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2024

First Posted

October 31, 2024

Study Start

November 1, 2024

Primary Completion

November 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations

CN(1)