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

To evaluate the efficacy and safety of Dual GIP/GLP-1 receptor agonist pretreatment on reproductive outcomes in obese women before frozen embryo transfer.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Frozen Embryo Transfer; Tirzepatide
• Intervention / Treatment: Drug: Dual GIP/GLP-1 receptor agonist

• Study Type: Interventional
• Enrollment (Estimated): 1510
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yun Sun, Professor; Phone Number: +86 20284574; Email: sunyun_rj@163.com
• Study Contact Backup: Name: Yao Lu; Phone Number: +86 20284574; Email: yaoluinrenji@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Renji Hospital
      • Contact: Yun Sun, Professor; Phone Number: +86 20284574; Email: sunyun_rj@163.com
      • Contact: Yao Lu; Phone Number: +86 20284574; Email: yaoluinrenji@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women aged 20-40 years;
2. Body Mass Index(BMI) ≥ 28kg/m2;
3. Women who intend to undergo frozen-thawed embryo transfer;
4. At least one embryo available for transfer;
5. Be capable of giving informed consent.

Exclusion Criteria:

1. Women who have been diagnosed with diseases affecting uterine cavity or endometrial receptivity;
2. Presence of endocrine disorders that may significantly affect body weight;
3. Use of drugs that may cause significant weight changes within 8 weeks before screening;
4. Presence of contraindications to the use of dual GIP/GLP-1 receptor agonist;
5. Previous bariatric surgery (e.g., gastric bypass) or planning to undergo such surgery during the study period;
6. Serum triglycerides (TG) > 5.64mmol/L;
7. Calcitonin≥50 ng/L;
8. Presence of medical contraindications to assisted reproductive technology and/or pregnancy;
9. Any other condition considered inappropriate for participation by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delayed FET; Participants 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.	Drug: Dual GIP/GLP-1 receptor agonist; 16 weeks treatment; Other Names: Tirzepatide
No Intervention: Standard FET; Participants will receive lifestyle modification guidance and proceed to FET with no predefined weight-loss target.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical pregnancy rate	biochemical pregnancy is defined as serum beta-human chorionic gonadotropin (β-hCG) ≥10 mIU/ml.	12-17 days after frozen embryo transfer
Clinical pregnancy rate	clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac.	28-35 days after frozen embryo transfer
Implantation rate	implantation rate is calculated as the number of gestational sacs by a transvaginal ultrasound scan/number of embryos transferred.	28-35 days after frozen embryo transfer
Pregnancy loss rate	pregnancy loss is defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.	From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months
Live birth rate	live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.	at delivery
Gestational weight gain	maternal weight gain during pregnancy.	at delivery
Incidences of obstetric and neonatal complications	including gestational diabetes mellitus, pre-eclampsia, placenta previa, placental abruption, congenital anomalies, postpartum hemorrhage, preterm birth, neonatal respiratory distress syndrome, neonatal jaundice, neonatal infection, neonatal death, etc.	From the establishment of clinically recognized pregnancy until six weeks after delivery
Incidence of composite endpoint of obesity-related pregnancy complications	composite incidences of miscarriage, gestational diabetes mellitus, hypertensive disorders of pregnancy, and preterm birth.	From the establishment of clinically recognized pregnancy until six weeks after delivery
Birth weight	birth weight of the newborn at delivery.	at delivery
Incidence of congenital anomalies	congenital malformations or birth defects.	From the establishment of clinically recognized pregnancy until six weeks after delivery

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Shandong University; The First Affiliated Hospital of Anhui Medical University; Shanghai Zhongshan Hospital; The Second Hospital of Hebei Medical University; Tongji Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of Zhengzhou University; Henan Provincial People's Hospital; Shanghai First Maternity and Infant Hospital; West China Second University Hospital; Nanjing Maternity and Child Health Care Hospital; Anhui Provincial Hospital; Jiangsu Provincial People's Hospital; Tianjin Central Hospital of Gynecology Obstetrics; Third Affiliated Hospital of Zhengzhou University; Northwest Women's and Children's Hospital, Xi'an, Shaanxi; Ningbo Women & Children's Hospital; Shenyang Jinghua Hospital; Shenyang Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: LY2026-062-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data
• IPD Sharing Time Frame: 1 year after publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No