ClinicalTrials.gg
Not yet recruitingNCT07811895Updated Sep 10, 2026

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

An interventional study of Dual GIP/GLP-1 receptor agonist in Tirzepatide, Frozen Embryo Transfer and Obesity, sponsored by RenJi Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,510
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Tirzepatide
  • Frozen Embryo Transfer
  • Obesity

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03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 1,510 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Women aged 20-40 years;
  2. (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 .

Exclusion criteria

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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,510 participants (estimated)

Study arms

  • 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

  • No intervention
    Standard FET

    Participants will receive lifestyle modification guidance and proceed to FET with no predefined weight-loss target.

Interventions

  • DrugDual GIP/GLP-1 receptor agonist

    16 weeks treatment

    Also known as: Tirzepatide

This study also gives Tirzepatide. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

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.

    Time frame: at delivery

Secondary outcomes

  1. Biochemical pregnancy rate

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

    Time frame: 12-17 days after frozen embryo transfer

  2. Clinical pregnancy rate

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

    Time frame: 28-35 days after frozen embryo transfer

  3. Implantation rate

    implantation rate is calculated as the number of gestational sacs by a transvaginal ultrasound scan/number of embryos transferred.

    Time frame: 28-35 days after frozen embryo transfer

  4. Pregnancy loss rate

    pregnancy loss is defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.

    Time frame: From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months

  5. Live birth rate

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

    Time frame: at delivery

  6. Gestational weight gain

    maternal weight gain during pregnancy.

    Time frame: at delivery

  7. 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.

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

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

    composite incidences of miscarriage, gestational diabetes mellitus, hypertensive disorders of pregnancy, and preterm birth.

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

  9. Birth weight

    birth weight of the newborn at delivery.

    Time frame: at delivery

  10. Incidence of congenital anomalies

    congenital malformations or birth defects.

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Deidentified participant data

Supporting information: Study protocol, Statistical analysis plan

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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07811895
Lead sponsor
RenJi Hospital
Collaborators
Shandong University, Shanghai Zhongshan Hospital, Shenyang Women's and Children's 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
Responsible party
Yun Sun (Professor, RenJi Hospital) — Principal investigator
First posted
Sep 10, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2029 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 10, 2026

Study contacts

Yun Sun, Professor
Contact
sunyun_rj@163.com
+86 20284574
Yao Lu
Contact
yaoluinrenji@163.com
+86 20284574

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Tirzepatide

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