Status:
NOT_YET_RECRUITING
Lipiodol Prior to FET (LIFE)
Lead Sponsor:
Mỹ Đức Hospital
Collaborating Sponsors:
Guerbet
Conditions:
IVF
Frozen Embryo Transfer
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Lipiodol® flushing is an effective fertility treatment for women with unexplained infertility. It is speculated that the treatment effect could work through a direct effect of Lipiodol® on the endomet...
Detailed Description
Study procedures: Recruitment: Potentially eligible patients will be given information about the study and a copy of the informed consent documents on day 2 - 3 of their menstrual cycle, when the ov...
Eligibility Criteria
Inclusion
- Women undergoing IVF/ICSI
- Having indications for freeze-all (day-3 or day-5)
- Agree to have ≤ 2 frozen embryos transferred
- TSH \< 2.5 mIU/mL
- Permanent resident in Viet Nam
- Agree to participate in the study by signing the inform consent
Exclusion
- Iodine allergy
- History of salpingectomy or tubal ligation
- History of using Lipiodol® within 6 months prior, starting from the screening time
- At high risk of having Fallopian tube disorders (history of Chlamydia infection, history of pelvic inflammatory diseases, current endometriosis)
- Having evidence of Fallopian tube disorders on Hysterosalpingo - Foam Sonography (HyFoSy), hysterosalpingography (HSG), ultrasonography or laparoscopy
- Having untreated intrauterine lesions such as endometrial polyps, submucosal fibroids, etc which affect the outcome of IVF treatment
- Have a history of thyroid disease or being treated for thyroid disease
- Undergoing curettage within 30 days before performing HSG technique
- Patients having embryos from oocyte donation or in vitro maturation (IVM) cycles
- Unable or unwilling to attend Lipiodol® procedure
- Participating in another interventional study at the same time
Key Trial Info
Start Date :
August 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
784 Patients enrolled
Trial Details
Trial ID
NCT06563908
Start Date
August 10 2024
End Date
December 1 2026
Last Update
August 21 2024
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