Not yet recruitingPhase NA

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

Lead sponsor

RenJi Hospital

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

1,510

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥28•Female

Primary endpoint

•Good birth outcome rate

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07811895

Org study IDLY2026-062-B

Timeline

Milestones

Study first posted2026-09-10actual

Last update posted2026-09-10actual

Study start2026-09estimated (month precision)

Primary completion2029-12estimated (month precision)

Study completion2030-12estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age20 Years

Maximum age40 Years

SexFemale

Healthy volunteersNot accepted

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.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Weight & body composition

Other clinical outcomes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Gestational weight gain

Time frame:at delivery

descriptive

Secondary/protocol endpoint

Birth weight

Time frame:at delivery

descriptive

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Incidence of composite endpoint of obesity-related pregnancy complications

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

event count, event

Secondary/protocol endpoint

Incidence of congenital anomalies

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

event count, event

Other (unclassified)

7 endpoints

Primary/protocol endpoint/low confidence

Good birth outcome rate

Time frame:at delivery

descriptive