Frozen Embryo Transfer, Obesity, Tirzepatide
Conditions
Brief 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.
Interventions
DRUGDual GIP/GLP-1 receptor agonist
16 weeks treatment
Sponsors
RenJi Hospital
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Good birth outcome rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy rate | 12-17 days after frozen embryo transfer | biochemical pregnancy is defined as serum beta-human chorionic gonadotropin (β-hCG) ≥10 mIU/ml. |
| Clinical pregnancy rate | 28-35 days after frozen embryo transfer | clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac. |
| Implantation rate | 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. |
| Pregnancy loss rate | 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. |
| Live birth rate | at delivery | live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation. |
| Gestational weight gain | at delivery | maternal weight gain during pregnancy. |
| Incidences of obstetric and neonatal complications | 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. |
| Incidence of composite endpoint of obesity-related pregnancy complications | 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. |
| Birth weight | at delivery | birth weight of the newborn at delivery. |
| Incidence of congenital anomalies | From the establishment of clinically recognized pregnancy until six weeks after delivery | congenital malformations or birth defects. |
Countries
China
Contacts
CONTACTYun Sun, Professor
CONTACTYao Lu
Outcome results
None listed