Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 5:03 AM
Study NCT ID:
NCT06666933
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-31
First Post:
2024-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate in PCOS Women With Glucose Metabolism Disorder Via IVF/ICSI
Sponsor:
RenJi Hospital
Organization:
Study Overview
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)
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: