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NCT Number: NCT07811895

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

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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Key information

Conditions

Tirzepatide Body Weight Frozen Embryo Transfer Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dual GIP/GLP-1 receptor agonist

Drug

16 weeks treatment

Other names: Tirzepatide

Primary outcomes

  1. Good birth outcome rate

    Time frame: 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

  1. Biochemical pregnancy rate

    Time frame: 12-17 days after frozen embryo transfer

    biochemical pregnancy is defined as serum beta-human chorionic gonadotropin (β-hCG) ≥10 mIU/ml.

  2. Clinical pregnancy rate

    Time frame: 28-35 days after frozen embryo transfer

    clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac.

  3. Implantation rate

    Time frame: 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.

  4. Pregnancy loss rate

    Time frame: 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.

  5. Live birth rate

    Time frame: at delivery

    live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.

  6. Gestational weight gain

    Time frame: at delivery

    maternal weight gain during pregnancy.

  7. Incidences of obstetric and neonatal complications

    Time frame: 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.

  8. Incidence of composite endpoint of obesity-related pregnancy complications

    Time frame: 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.

  9. Birth weight

    Time frame: at delivery

    birth weight of the newborn at delivery.

  10. Incidence of congenital anomalies

    Time frame: From the establishment of clinically recognized pregnancy until six weeks after delivery

    congenital malformations or birth defects.

Study contacts

Contact information is provided by the study sponsor or research team.

Yao Lu

CONTACT

[email protected]

+86 20284574

Yun Sun, Professor

CONTACT

[email protected]

+86 20284574

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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