Lipiodol® For Enhancing Live Birth Rates In Infertile Couples Undergoing In Vitro Fertilization/ Intracytoplasmic Sperm Injection A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 784
- 主要终点
- Live birth rate after the first transfer
研究概览
简要总结
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.
详细描述
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 ovarian stimulation starts. On the day of freeze-all (3 days or 5 days after oocyte retrieval), screening for eligibility will be performed by treating physicians. Eligible couples will have about an hour to decide if they will participate in the study or not. If they choose to participate in the study, investigators will ask them to sign the consent form.
Once a participant signs an informed consent she is enrolled in the study. An individual record of all non-recruited patients and reasons for exclusion (at any stage) will be obtained and stored
Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Live birth rate after the first transfer
时间窗: At 22 weeks of gestation
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
次要结局
- Multiple pregnancy(At 7 weeks after embryo(s) placement)
- Positive pregnancy test(At 2 weeks after embryo(s) placement)
- Clinical pregnancy rate(At 5 weeks after embryo(s) placement)
- Ongoing pregnancy rate(At 10 weeks after embryo(s) placement)
- Cumulative live birth rate at 12 months after randomization(At 12 months after randomization)
- Ectopic pregnancy rate(At 12 weeks of gestation)
- Early miscarriage rate (Miscarriage <12 weeks)(At 12 weeks of gestation)
- Late miscarriage rate (Miscarriage <22 weeks)(At 22 weeks of gestation)
- Still birth rate(After 22 weeks of gestation)
- Adverse events(At delivery)
- Maternal thyroid function(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(At 24-28 weeks of gestation)
- Hypertensive disorders of pregnancy rate(From date of randomization until the date of first documented progression, assessed up to 12 months after randomization)
- Preterm birth rate(At 22, 28, 32 and 37 weeks of gestation)
- Premature rupture of membranes rate(At 37 weeks of gestation)
- Chorioamnionitis rate(At delivery)
- Percentage of magnesium sulfate administration for neuroprotection(At delivery)
- Large for gestational age(At delivery)
- Small for gestational age(At delivery)
- Gestational age at birth(At delivery)
- Antenatal corticosteroids for lung maturation(At delivery)
- Administration of tocolytics agents(At delivery)
- Birth weight(At delivery)
- Mode of delivery(At delivery)
- Congenital anomalies(Within 28 days of birth)
- Neonatal mortality(Within 28 days of birth)
- 5-minute Apgar score(At 5 minute after birth)
- Low 5-minute Apgar score(At 5 minute after birth)
- Postpartum hemorrhage(At delivery)
- Maternal death(At delivery)
- neonatal intensive care unit (NICU) admission(Within 28 days of birth)
- 1-minute Apgar score(At 1 minute after birth)
- Neonatal thyroid function(At delivery)
- Mode of conception(From date of randomization until the date of pregnancy test or date of ultrasound, whichever came first, assessed up to 12 months)