Dual GIP/GLP-1 Receptor Agonist in Obese Women Before Frozen Embryo Transfer

NCT07811895 — Not applicable, Not yet recruiting, 1510 participants, RenJi Hospital

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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

Registry	NCT07811895
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	1510 (Estimated)
Sponsor	RenJi Hospital (Other); collaborators: Shandong University, Shanghai Zhongshan Hospital, Shenyang Maternal and Child Health Hospital, Third Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital, The Second Hospital of Hebei Medical University, Jiangsu 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, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Shenyang Jinghua Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Zhengzhou University, Tongji Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Tianjin Central Hospital of Gynecology Obstetrics, Ningbo Women & Children's Hospital
Conditions	Tirzepatide, Frozen Embryo Transfer, Obesity
Interventions	Dual GIP/GLP-1 receptor agonist (Drug)
Dates	start 2026-09-01 (estimated), primary completion 2029-12-01 (estimated), completion 2030-12-01 (estimated), first posted 2026-09-10, last updated 2026-09-10
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Delayed FET	Experimental	Drug: Dual GIP/GLP-1 receptor agonist	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.
Standard FET	No intervention		Participants will receive lifestyle modification guidance and proceed to FET with no predefined weight-loss target.

Dual GIP/GLP-1 receptor agonist (Drug), also known as Tirzepatide: 16 weeks treatment

+Outcome measures

Primary outcomes

Good birth outcome rate [at delivery]: 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.

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 20 Years to 40 Years

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.

+Locations (1)

Facility	City	Country	Status
RenJi Hospital	Shanghai, Shanghai Municipality	China