Dual GIP/GLP-1 Receptor Agonist in Obese Women Before Frozen Embryo Transfer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorRenJi Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Dual GIP/GLP-1 receptor agonist
Drug16 weeks treatment
Treatment groups
1,510 Participants
are divided into 2 treatment groupsGroup A: Delayed FETExperimental treatment 1 intervention
Group B: Standard FETNo intervention 0 interventions
Trial outcomes
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 deliverySecondary 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 transfer2
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 transfer3
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 transfer4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
RenJi Hospital
Lead sponsor
Shandong University
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Shenyang Women's and Children's Hospital
Collaborator
Third Affiliated Hospital of Zhengzhou University
Collaborator
Henan Provincial People's Hospital
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Jiangsu Provincial People's Hospital
Collaborator
Shanghai First Maternity and Infant Hospital
Collaborator
West China Second University Hospital
Collaborator
Nanjing Maternity and Child Health Care Hospital
Collaborator
Anhui Provincial Hospital
Collaborator
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Collaborator
Shenyang Jinghua Hospital
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Tongji Hospital
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Tianjin Central Hospital of Gynecology Obstetrics
Collaborator
Ningbo Women & Children's Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: