Lipiodol Prior to FET (LIFE)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorMỹ Đức Hospital
About this trial
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 endometrium. Given this direct effect on the endometrium, it is further hypothesized that Lipiodol® uterine treatment prior to In Vitro Fertilization (IVF)/ Intracytoplasmic Sperm Injection (ICSI) may also improve pregnancy rates. However, the effectiveness of Lipiodol® as an adjunct to IVF/ICSI treatment has not previously been examined in a well-powered and properly conducted randomised clinical trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Lipiodol® uterine treatment prior to IVF/ICSI
Procedure/SurgeryLipiodol®, treatment will be performed by a HSG technique with X-ray screening on day 3 or day 5 after oocyte retrieval. The contrast medium will be Lipiodol Ultra Fluide® (Guerbet, France), an iodized poppy seed oil obtained by substitution of ethyl esters for the glyceryl esters of Lipiodol®. One millilitre of Lipiodol Ultra Fluide® contains 0.48g iodine. Women will lie in the left lateral or supine position. Radiologists will use a 'no touch' technique after applying antiseptic solution to the cervix. Uterine cannulation using the Cook HSG catheter will be applied to conduct Lipiodol® treatment. Prewarmed (37oC) Lipiodol® will be slowly instilled, with intermittent fluoroscopic X-ray guidance. Up to 10 ml of Lipiodol® will be slowly injected into the uterus and directly monitored by fluoroscopy. If intravasation was observed on X-ray (contrast apparent in the venous system), instillation will be stopped immediately.
Treatment groups
784 Participants
are divided into 2 treatment groupsGroup A: Lipiodol® uterine treatment prior to IVF/ICSIExperimental treatment 1 intervention
Group B: No Lipiodol® uterine treatment prior to IVF/ICSINo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Live birth rate after the first transfer
Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age, which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. If gestational age is unknown, a birth weight of 500 grams or more will be used instead
Time frame
At 22 weeks of gestationSecondary outcomes
1
Positive pregnancy test
Serum human chorionic gonadotropin level greater than 25 mIU/mL (milli-International Unit per milliliter)
Time frame
At 2 weeks after embryo(s) placement2
Clinical pregnancy rate
Clinical pregnancy is diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy at 6 weeks or more after the onset of last menstrual period. In addition to intra-uterine pregnancy, it includes a clinically documented ectopic pregnancy
Time frame
At 5 weeks after embryo(s) placement3
Ongoing pregnancy rate
Ongoing pregnancy is a pregnancy with a detectable heart rate at 12 weeks gestation or beyond
Time frame
At 10 weeks after embryo(s) placement4
Multiple pregnancy
The presence of more than one gestational sac at early pregnancy ultrasound (6-9 weeks gestation)
Time frame
At 7 weeks after embryo(s) placementLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mỹ Đức Hospital
Lead sponsor
Guerbet
Collaborator
Source ClinicalTrials.gov
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