Lipiodol Prior to FET (LIFE)
NCT Number: NCT06563908
Acronym: LIFE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: IVF|Frozen Embryo Transfer|Hysterosalpingography
Interventions: PROCEDURE: Lipiodol® uterine treatment prior to IVF/ICSI
Sponsor: Mỹ Đức Hospital
Collaborators: Guerbet
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 784
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2026-12

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 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.

Primary Outcome Measures: 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, At 22 weeks of gestation
Secondary Outcome Measures: Positive pregnancy test, Serum human chorionic gonadotropin level greater than 25 mIU/mL (milli-International Unit per milliliter), At 2 weeks after embryo(s) placement|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, At 5 weeks after embryo(s) placement|Ongoing pregnancy rate, Ongoing pregnancy is a pregnancy with a detectable heart rate at 12 weeks gestation or beyond, At 10 weeks after embryo(s) placement|Multiple pregnancy, The presence of more than one gestational sac at early pregnancy ultrasound (6-9 weeks gestation), At 7 weeks after embryo(s) placement|Cumulative live birth rate at 12 months after randomization, Cumulative live birth at 12 months after randomization, At 12 months after randomization|Ectopic pregnancy rate, A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology, At 12 weeks of gestation|Early miscarriage rate (Miscarriage <12 weeks), A spontaneous loss of pregnancy up to 12 weeks of gestation., At 12 weeks of gestation|Late miscarriage rate (Miscarriage <22 weeks), A spontaneous loss of pregnancy between 12 to 22 weeks., At 22 weeks of gestation|Still birth rate, The death of a fetus prior to the complete expulsion or extraction from its mother after 20 completed weeks of gestational age. The death is determined by the fact that, after such separation, the fetus does not breathe or show any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles. It includes deaths occurring during labor, After 22 weeks of gestation|Adverse events, Include intravasation of Lipiodol® and lipogranuloma formation, as well as all other adverse events, At delivery|Maternal thyroid function, Serum TSH and FT4, At the day of pregnancy test, 3 months (at 7 weeks of pregnancy if the patient is pregnant) and 6 months (at 22 weeks of pregnancy if the patient is pregnant) after randomization|Gestational diabetes mellitus rate, Using a 75g oral glucose tolerance test, with plasma glucose measurement when patient is fasting and at 1 and 2 h, at 24-28 weeks of gestation in women not previously diagnosed with diabetes.

* Fasting: 92 mg/dL (5.1 mmol/L)
* 1 h: 180 mg/dL (10.0 mmol/L)
* 2 h: 153 mg/dL (8.5 mmol/L), At 24-28 weeks of gestation|Hypertensive disorders of pregnancy rate, Percentage of pregnancy-induced hypertension (PIH), pre-eclampsia (PET), eclampsia, and HELLP syndrome, From date of randomization until the date of first documented progression, assessed up to 12 months after randomization|Preterm birth rate, Defined as any delivery at \<24, \<28, \<32, \<37 completed weeks' gestation, At 22, 28, 32 and 37 weeks of gestation|Premature rupture of membranes rate, A rupture of the membranes (amniotic sac) prior to 37 weeks' gestation., At 37 weeks of gestation|Chorioamnionitis rate, Chorioamnionitis is defined as intraamniotic infection with resultant inflammation of any combination of the amniotic fluid, placenta, fetus, fetal membranes, or decidua, At delivery|Percentage of magnesium sulfate administration for neuroprotection, Administration of magnesium sulfate for preventing seizures in case of preeclampsia/eclampsia, At delivery|Antenatal corticosteroids for lung maturation, Administration of corticosteroids prior to preterm birth, At delivery|Administration of tocolytics agents, Administration of tocolytics agents to prevent preterm birth, At delivery|Birth weight, including low birth weight (defined as weight \< 2,500 gram at birth), very low birth weight (defined as \< 1,500 gram at birth), high birth weight (defined as \>4,000 gram at birth) and very high birth weight (defined as \>4,500 gram at birth), At delivery|Large for gestational age, Birth weight \>90th centile for gestation, based on standardized ethnicity-based charts, At delivery|Small for gestational age, Birth weight \<10th centile for gestation age based on standardized ethnicity-based charts, At delivery|Gestational age at birth, Calculated by gestational age of all live births, At delivery|Mode of delivery, including vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor), At delivery|Postpartum hemorrhage, Cumulative blood loss greater than or equal to 1,000 mL or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after the birth process (includes intrapartum loss) regardless of route of delivery, At delivery|Maternal death, Female deaths from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, At delivery|Congenital anomalies, Structural or functional disorders that occur during intra-uterine life and can be identified prenatally, at birth or later in life, Within 28 days of birth|Neonatal mortality, Death of a live born baby within 28 days of birth, Within 28 days of birth|neonatal intensive care unit (NICU) admission, The admittance of the newborn to NICU, Within 28 days of birth|1-minute Apgar score, The Apgar score at 1 minute after birth, At 1 minute after birth|5-minute Apgar score, The Apgar score at 5 minute after birth, At 5 minute after birth|Low 5-minute Apgar score, Defined as 5-minute Apgar score \<7., At 5 minute after birth|Neonatal thyroid function, Serum thyroid-stimulating hormone (TSH) and free thyroxine (fT4), At delivery|Mode of conception, Including natural conception, intrauterine insemination (IUI), and in vitro fertilization (IVF), From date of randomization until the date of pregnancy test or date of ultrasound, whichever came first, assessed up to 12 months