Dual GIP/GLP-1 Receptor Agonist in Obese Women Before Frozen Embryo Transfer
Dual Glucose-dependent Insulinotropic Peptide (GIP) and Glucagon-like Peptide-1 (GLP-1) Receptor Agonist in Women With Obesity for Frozen Embryo Transfer (FET): Pragmatic, Multicenter, Randomized Controlled Trial
1 other identifier
interventional
1,510
1 country
1
Brief Summary
To evaluate the efficacy and safety of Dual GIP/GLP-1 receptor agonist pretreatment on reproductive outcomes in obese women before frozen embryo transfer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
August 27, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedFirst Posted
Study publicly available on registry
September 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
September 10, 2026
July 1, 2026
3.3 years
August 27, 2026
September 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Good birth outcome rate
good birth outcome is defined as live birth(s) at ≥37 weeks, with infant birth weight between 2500 and 4000g and without a major congenital anomaly.
at delivery
Secondary Outcomes (10)
Biochemical pregnancy rate
12-17 days after frozen embryo transfer
Clinical pregnancy rate
28-35 days after frozen embryo transfer
Implantation rate
28-35 days after frozen embryo transfer
Pregnancy loss rate
From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months
Live birth rate
at delivery
- +5 more secondary outcomes
Study Arms (2)
Delayed FET
EXPERIMENTALParticipants will receive 16-week tirzepatide pretreatment prior to FET alongside lifestyle modification guidance, with a target weight loss of 10%-15% of total body weight.
Standard FET
NO INTERVENTIONParticipants will receive lifestyle modification guidance and proceed to FET with no predefined weight-loss target.
Interventions
Eligibility Criteria
You may qualify if:
- Women aged 20-40 years;
- Body Mass Index(BMI) ≥ 28kg/m2;
- Women who intend to undergo frozen-thawed embryo transfer;
- At least one embryo available for transfer;
- Be capable of giving informed consent.
You may not qualify if:
- Women who have been diagnosed with diseases affecting uterine cavity or endometrial receptivity;
- Presence of endocrine disorders that may significantly affect body weight;
- Use of drugs that may cause significant weight changes within 8 weeks before screening;
- Presence of contraindications to the use of dual GIP/GLP-1 receptor agonist;
- Previous bariatric surgery (e.g., gastric bypass) or planning to undergo such surgery during the study period;
- Serum triglycerides (TG) \> 5.64mmol/L;
- Calcitonin≥50 ng/L;
- Presence of medical contraindications to assisted reproductive technology and/or pregnancy;
- Any other condition considered inappropriate for participation by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
- Shandong Universitycollaborator
- Shanghai Zhongshan Hospitalcollaborator
- Shenyang Women's and Children's Hospitalcollaborator
- Third Affiliated Hospital of Zhengzhou Universitycollaborator
- Henan Provincial People's Hospitalcollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- Jiangsu Provincial People's Hospitalcollaborator
- Shanghai First Maternity and Infant Hospitalcollaborator
- West China Second University Hospitalcollaborator
- Nanjing Maternity and Child Health Care Hospitalcollaborator
- Anhui Provincial Hospitalcollaborator
- Northwest Women's and Children's Hospital, Xi'an, Shaanxicollaborator
- Shenyang Jinghua Hospitalcollaborator
- The First Affiliated Hospital of Anhui Medical Universitycollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Tongji Hospitalcollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoolcollaborator
- Tianjin Central Hospital of Gynecology Obstetricscollaborator
- Ningbo Women & Children's Hospitalcollaborator
Study Sites (1)
RenJi Hospital
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 27, 2026
First Posted
September 10, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2030
Last Updated
September 10, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 1 year after publication
- Access Criteria
- The data of this study are available on request from the corresponding author. Investigators requesting data will need to provide a written protocol with an analysis plan and sign a data-sharing/access agreement. Use of the data will require approval from a designated independent review committee.
Deidentified participant data