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

September 3, 2026 updated by: Yun Sun, RenJi Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1510

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12-17 days after frozen embryo transfer
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.
28-35 days after frozen embryo transfer
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.
28-35 days after frozen embryo transfer
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.
From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months
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.
at delivery
Gestational weight gain
Time Frame: at delivery
maternal weight gain during pregnancy.
at delivery
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.
From the establishment of clinically recognized pregnancy until six weeks after delivery
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.
From the establishment of clinically recognized pregnancy until six weeks after delivery
Birth weight
Time Frame: at delivery
birth weight of the newborn at delivery.
at delivery
Incidence of congenital anomalies
Time Frame: From the establishment of clinically recognized pregnancy until six weeks after delivery
congenital malformations or birth defects.
From the establishment of clinically recognized pregnancy until six weeks after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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