Lipiodol Prior to FET (LIFE)

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

Serum human chorionic gonadotropin level greater than 25 mIU/mL (milli-International Unit per milliliter)

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

Ongoing pregnancy is a pregnancy with a detectable heart rate at 12 weeks gestation or beyond

The presence of more than one gestational sac at early pregnancy ultrasound (6-9 weeks gestation)

Cumulative live birth at 12 months after randomization

A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology

A spontaneous loss of pregnancy up to 12 weeks of gestation.

A spontaneous loss of pregnancy between 12 to 22 weeks.

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

Include intravasation of Lipiodol® and lipogranuloma formation, as well as all other adverse events

Serum TSH and FT4

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)

Percentage of pregnancy-induced hypertension (PIH), pre-eclampsia (PET), eclampsia, and HELLP syndrome

Defined as any delivery at <24, <28, <32, <37 completed weeks' gestation

A rupture of the membranes (amniotic sac) prior to 37 weeks' gestation.

Chorioamnionitis is defined as intraamniotic infection with resultant inflammation of any combination of the amniotic fluid, placenta, fetus, fetal membranes, or decidua

Administration of magnesium sulfate for preventing seizures in case of preeclampsia/eclampsia

Administration of corticosteroids prior to preterm birth

Administration of tocolytics agents to prevent preterm birth

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)

Birth weight >90th centile for gestation, based on standardized ethnicity-based charts

Birth weight <10th centile for gestation age based on standardized ethnicity-based charts

Calculated by gestational age of all live births

including vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor)

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

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

Structural or functional disorders that occur during intra-uterine life and can be identified prenatally, at birth or later in life

Death of a live born baby within 28 days of birth

The admittance of the newborn to NICU

The Apgar score at 1 minute after birth

The Apgar score at 5 minute after birth

Defined as 5-minute Apgar score <7.

Serum thyroid-stimulating hormone (TSH) and free thyroxine (fT4)

Including natural conception, intrauterine insemination (IUI), and in vitro fertilization (IVF)