Dual GIP/GLP-1 Receptor Agonist in Obese Women Before Frozen Embryo Transfer
3. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1510
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yun Sun, Professor
- Telefonnummer: +86 20284574
- E-mail: sunyun_rj@163.com
Undersøgelse Kontakt Backup
- Navn: Yao Lu
- Telefonnummer: +86 20284574
- E-mail: yaoluinrenji@163.com
Studiesteder
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200025
- Renji Hospital
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Kontakt:
- Yun Sun, Professor
- Telefonnummer: +86 20284574
- E-mail: sunyun_rj@163.com
-
Kontakt:
- Yao Lu
- Telefonnummer: +86 20284574
- E-mail: yaoluinrenji@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
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16 weeks treatment
Andre navne:
|
|
Ingen indgriben: Standard FET
Participants will receive lifestyle modification guidance and proceed to FET with no predefined weight-loss target.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Good birth outcome rate
Tidsramme: at delivery
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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.
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at delivery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Biochemical pregnancy rate
Tidsramme: 12-17 days after frozen embryo transfer
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biochemical pregnancy is defined as serum beta-human chorionic gonadotropin (β-hCG) ≥10 mIU/ml.
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12-17 days after frozen embryo transfer
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Clinical pregnancy rate
Tidsramme: 28-35 days after frozen embryo transfer
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clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac.
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28-35 days after frozen embryo transfer
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Implantation rate
Tidsramme: 28-35 days after frozen embryo transfer
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implantation rate is calculated as the number of gestational sacs by a transvaginal ultrasound scan/number of embryos transferred.
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28-35 days after frozen embryo transfer
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Pregnancy loss rate
Tidsramme: From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months
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pregnancy loss is defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.
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From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months
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Live birth rate
Tidsramme: at delivery
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live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.
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at delivery
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Gestational weight gain
Tidsramme: at delivery
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maternal weight gain during pregnancy.
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at delivery
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Incidences of obstetric and neonatal complications
Tidsramme: From the establishment of clinically recognized pregnancy until six weeks after delivery
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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.
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From the establishment of clinically recognized pregnancy until six weeks after delivery
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Incidence of composite endpoint of obesity-related pregnancy complications
Tidsramme: From the establishment of clinically recognized pregnancy until six weeks after delivery
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composite incidences of miscarriage, gestational diabetes mellitus, hypertensive disorders of pregnancy, and preterm birth.
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From the establishment of clinically recognized pregnancy until six weeks after delivery
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Birth weight
Tidsramme: at delivery
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birth weight of the newborn at delivery.
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at delivery
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Incidence of congenital anomalies
Tidsramme: From the establishment of clinically recognized pregnancy until six weeks after delivery
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congenital malformations or birth defects.
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From the establishment of clinically recognized pregnancy until six weeks after delivery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. december 2029
Studieafslutning (Anslået)
1. december 2030
Datoer for studieregistrering
Først indsendt
27. august 2026
Først indsendt, der opfyldte QC-kriterier
3. september 2026
Først opslået (Faktiske)
10. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. september 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Overernæring
- Kropsvægt
- Overvægtig
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Fedme
- Aminosyrer, peptider og proteiner
- Proteiner
- Glucagon-lignende peptid-1-receptor
- Glucagon-lignende peptidreceptorer
- Receptorer, G-protein-koblet
- Receptorer, celleoverflade
- Membranproteiner
- Receptorer, gastrointestinal hormon
- Receptorer, peptid
- Tirzepatid
Andre undersøgelses-id-numre
- LY2026-062-B
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Deidentified participant data
IPD-delingstidsramme
1 year after publication
IPD-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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