IVFLIFENCT06563908
Lipiodol Prior to FET (LIFE)
A study testing Lipiodol® uterine treatment prior to IVF/ICSI in people with IVF and Frozen Embryo Transfer, run by Mỹ Đức Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- IVF, Frozen Embryo Transfer, Hysterosalpingography
- What is being tested?
- Lipiodol® uterine treatment prior to IVF/ICSI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 784 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Lipiodol® For Enhancing Live Birth Rates In Infertile Couples Undergoing In Vitro Fertilization/ Intracytoplasmic Sperm Injection A Randomized Controlled 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.
Read the 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 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:
Assignment to treatment allocation will be done via a web portal hosted by Hope Research Center, Viet Nam. The randomisation schedule will be computer-generated at Hope Research Center by using HRC (Hope Research Center) Epi software, in a 1:1 ratio, with a permuted random block size of 4 or 6.
Other standard assisted reproductive treatments are similar and parallel between the two groups, except for the use of Lipiodol® flushing in the intervention group. Due to the type of interventions, this study will only be blinded to clinicians who performed the embryo transfer and embryologists in the IVF clinics.
In the subsequent cycle, all patients in both groups will undergo frozen embryo transfer by using exogenous steroids regimen, starting from day 2 to day 4 of the menstrual cycle. Oral estradiol valerate (Progynova, Bayer Schering Pharma, Germany) 8 mg/day is given for 10-12 days. Ultrasound monitoring will be performed from day tenth onward. When endometrial thickness reaches greater than or equal to 8 mm, along with a triple-line pattern, micronized progesterone 800 mg will be administrated. Frozen embryo transfer (FET) will be performed 3-5 days after progesterone administration, depending on embryo staging. After FET, estradiol and progesterone supplementation are continued for all patients until the day of the pregnancy test. Patients with a positive pregnancy test will continue to receive luteal phase support regimen until 7 weeks of gestation.
All participants will be followed up per local protocol until outcomes are achieved
- Conditions
- IVF, Frozen Embryo Transfer, Hysterosalpingography
- Being tested
- Lipiodol® uterine treatment prior to IVF/ICSI
- Keywords
- Lipiodol, Hysterosalpingography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipiodol® uterine treatment prior to IVF/ICSIProcedure or surgery
Also called Lipiodol® flushing prior to IVF/ICSI
Lipiodol®, 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.
| Study group | Role | What they receive |
|---|---|---|
| Lipiodol® uterine treatment prior to IVF/ICSI | Experimental | For those who are randomized to Lipiodol®, 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®. After that the procedure to assess study participants' pain perception.
Endometrial preparation for frozen embryo transfer will perform on the subsequence cycle Receives: Procedure: Lipiodol® uterine treatment prior to IVF/ICSI |
| No Lipiodol® uterine treatment prior to IVF/ICSI | No intervention | For those who are randomized to no intervention arm (control group), there will be no HSG performed. Endometrial preparation for frozen embryo transfer will perform on the subsequence cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 22 weeks of gestation
Secondary outcomes (34)
Positive pregnancy test
Serum human chorionic gonadotropin level greater than 25 mIU/mL (milli-International Unit per milliliter)
Measured: 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
Measured: 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
Measured: 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)
Measured: At 7 weeks after embryo(s) placement
Cumulative live birth rate at 12 months after randomization
Cumulative live birth at 12 months after randomization
Measured: At 12 months after randomization
Ectopic pregnancy rate
A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology
Measured: At 12 weeks of gestation
Early miscarriage rate (Miscarriage <12 weeks)
A spontaneous loss of pregnancy up to 12 weeks of gestation.
Measured: At 12 weeks of gestation
Late miscarriage rate (Miscarriage <22 weeks)
A spontaneous loss of pregnancy between 12 to 22 weeks.
Measured: 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
Measured: After 22 weeks of gestation
Adverse events
Include intravasation of Lipiodol® and lipogranuloma formation, as well as all other adverse events
Measured: At delivery
Maternal thyroid function
Serum TSH and FT4
Measured: 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)
Measured: At 24-28 weeks of gestation
Hypertensive disorders of pregnancy rate
Percentage of pregnancy-induced hypertension (PIH), pre-eclampsia (PET), eclampsia, and HELLP syndrome
Measured: 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
Measured: 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.
Measured: 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
Measured: At delivery
Percentage of magnesium sulfate administration for neuroprotection
Administration of magnesium sulfate for preventing seizures in case of preeclampsia/eclampsia
Measured: At delivery
Antenatal corticosteroids for lung maturation
Administration of corticosteroids prior to preterm birth
Measured: At delivery
Administration of tocolytics agents
Administration of tocolytics agents to prevent preterm birth
Measured: 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)
Measured: At delivery
Large for gestational age
Birth weight >90th centile for gestation, based on standardized ethnicity-based charts
Measured: At delivery
Small for gestational age
Birth weight <10th centile for gestation age based on standardized ethnicity-based charts
Measured: At delivery
Gestational age at birth
Calculated by gestational age of all live births
Measured: At delivery
Mode of delivery
including vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor)
Measured: 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
Measured: 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
Measured: 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
Measured: Within 28 days of birth
Neonatal mortality
Death of a live born baby within 28 days of birth
Measured: Within 28 days of birth
neonatal intensive care unit (NICU) admission
The admittance of the newborn to NICU
Measured: Within 28 days of birth
1-minute Apgar score
The Apgar score at 1 minute after birth
Measured: At 1 minute after birth
5-minute Apgar score
The Apgar score at 5 minute after birth
Measured: At 5 minute after birth
Low 5-minute Apgar score
Defined as 5-minute Apgar score <7.
Measured: At 5 minute after birth
Neonatal thyroid function
Serum thyroid-stimulating hormone (TSH) and free thyroxine (fT4)
Measured: At delivery
Mode of conception
Including natural conception, intrauterine insemination (IUI), and in vitro fertilization (IVF)
Measured: From date of randomization until the date of pregnancy test or date of ultrasound, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 784 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563908
- Sponsor's protocol ID
- 1767/QD-BYT
- Acronym
- LIFE
- Status last verified
- Jul 2024
- First submitted
- 1 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thoma ME, McLain AC, Louis JF, King RB, Trumble AC, Sundaram R, Buck Louis GM. Prevalence of infertility in the United States as estimated by the current duration approach and a traditional constructed approach. Fertil Steril. 2013 Apr;99(5):1324-1331.e1. doi: 10.1016/j.fertnstert.2012.11.037. Epub 2013 Jan 3.
PubMed 23290741Abrao MS, Muzii L, Marana R. Anatomical causes of female infertility and their management. Int J Gynaecol Obstet. 2013 Dec;123 Suppl 2:S18-24. doi: 10.1016/j.ijgo.2013.09.008. Epub 2013 Sep 11.
PubMed 24119894WEIR WC, WEIR DR. Therapeutic value of salpingograms in infertility. Fertil Steril. 1951 Nov-Dec;2(6):514-22. doi: 10.1016/s0015-0282(16)30725-7. No abstract available.
PubMed 14887769KING EL, HERRING JS. Sterility studies in private practice. Am J Obstet Gynecol. 1949 Aug;58(2):258-66. doi: 10.1016/0002-9378(49)90378-6. No abstract available.
PubMed 18133559Watson A, Vandekerckhove P, Lilford R, Vail A, Brosens I, Hughes E. A meta-analysis of the therapeutic role of oil soluble contrast media at hysterosalpingography: a surprising result? Fertil Steril. 1994 Mar;61(3):470-7. doi: 10.1016/s0015-0282(16)56578-9.
PubMed 8137969Mohiyiddeen L, Hardiman A, Fitzgerald C, Hughes E, Mol BW, Johnson N, Watson A. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2015 May 1;2015(5):CD003718. doi: 10.1002/14651858.CD003718.pub4.
PubMed 25929235Dreyer K, van Rijswijk J, Mijatovic V, Goddijn M, Verhoeve HR, van Rooij IAJ, Hoek A, Bourdrez P, Nap AW, Rijnsaardt-Lukassen HGM, Timmerman CCM, Kaplan M, Hooker AB, Gijsen AP, van Golde R, van Heteren CF, Sluijmer AV, de Bruin JP, Smeenk JMJ, de Boer JAM, Scheenjes E, Duijn AEJ, Mozes A, Pelinck MJ, Traas MAF, van Hooff MHA, van Unnik GA, de Koning CH, van Geloven N, Twisk JWR, Hompes PGA, Mol BWJ. Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile Women. N Engl J Med. 2017 May 25;376(21):2043-2052. doi: 10.1056/NEJMoa1612337. Epub 2017 May 18.
PubMed 28520519Johnson JV, Montoya IA, Olive DL. Ethiodol oil contrast medium inhibits macrophage phagocytosis and adherence by altering membrane electronegativity and microviscosity. Fertil Steril. 1992 Sep;58(3):511-7. doi: 10.1016/s0015-0282(16)55254-6.
PubMed 1325928Sawatari Y, Horii T, Hoshiai H. Oily contrast medium as a therapeutic agent for infertility because of mild endometriosis. Fertil Steril. 1993 Apr;59(4):907-11. doi: 10.1016/s0015-0282(16)55880-4.
PubMed 8384577Mikulska D, Kurzawa R, Rozewicka L. Morphology of in vitro sperm phagocytosis by rat peritoneal macrophages under influence of oily contrast medium (Lipiodol). Acta Eur Fertil. 1994 May-Jun;25(3):203-6.
PubMed 7900503Johnson NP, Farquhar CM, Hadden WE, Suckling J, Yu Y, Sadler L. The FLUSH trial--flushing with lipiodol for unexplained (and endometriosis-related) subfertility by hysterosalpingography: a randomized trial. Hum Reprod. 2004 Sep;19(9):2043-51. doi: 10.1093/humrep/deh418. Epub 2004 Jul 22.
PubMed 15271870Johnson NP, Bhattu S, Wagner A, Blake DA, Chamley LW. Lipiodol alters murine uterine dendritic cell populations: a potential mechanism for the fertility-enhancing effect of lipiodol. Fertil Steril. 2005 Jun;83(6):1814-21. doi: 10.1016/j.fertnstert.2004.11.065.
PubMed 15950655Reilly SJ, Glanville EJ, Dhorepatil B, Prentice LR, Mol BW, Johnson NP. The IVF-LUBE trial - a randomized trial to assess Lipiodol(R) uterine bathing effect in women with endometriosis or repeat implantation failure undergoing IVF. Reprod Biomed Online. 2019 Mar;38(3):380-386. doi: 10.1016/j.rbmo.2018.11.015. Epub 2018 Dec 7.
PubMed 30679138Fatourechi V. Subclinical hypothyroidism: an update for primary care physicians. Mayo Clin Proc. 2009;84(1):65-71. doi: 10.4065/84.1.65.
PubMed 19121255
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipiodol® For Enhancing Live Birth Rates In Infertile Couples Undergoing In Vitro Fertilization/ Intracytoplasmic Sperm Injection A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06563908
- Acronym / sponsor ID
- LIFE / 1767/QD-BYT
- Conditions
- IVF, Frozen Embryo Transfer, Hysterosalpingography
- Keywords
- Lipiodol, Hysterosalpingography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 784 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
Assignment to treatment allocation will be done via a web portal hosted by Hope Research Center, Viet Nam. The randomisation schedule will be computer-generated at Hope Research Center by using HRC (Hope Research Center) Epi software, in a 1:1 ratio, with a permuted random block size of 4 or 6.
Other standard assisted reproductive treatments are similar and parallel between the two groups, except for the use of Lipiodol® flushing in the intervention group. Due to the type of interventions, this study will only be blinded to clinicians who performed the embryo transfer and embryologists in the IVF clinics.
In the subsequent cycle, all patients in both groups will undergo frozen embryo transfer by using exogenous steroids regimen, starting from day 2 to day 4 of the menstrual cycle. Oral estradiol valerate (Progynova, Bayer Schering Pharma, Germany) 8 mg/day is given for 10-12 days. Ultrasound monitoring will be performed from day tenth onward. When endometrial thickness reaches greater than or equal to 8 mm, along with a triple-line pattern, micronized progesterone 800 mg will be administrated. Frozen embryo transfer (FET) will be performed 3-5 days after progesterone administration, depending on embryo staging. After FET, estradiol and progesterone supplementation are continued for all patients until the day of the pregnancy test. Patients with a positive pregnancy test will continue to receive luteal phase support regimen until 7 weeks of gestation.
All participants will be followed up per local protocol until outcomes are achieved
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipiodol® uterine treatment prior to IVF/ICSI | Experimental | Procedure: Lipiodol® uterine treatment prior to IVF/ICSIFor those who are randomized to Lipiodol®, 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®. After that the procedure to assess study participants' pain perception. Endometrial preparation for frozen embryo transfer will perform on the subsequence cycle |
| No Lipiodol® uterine treatment prior to IVF/ICSI | No intervention | –For those who are randomized to no intervention arm (control group), there will be no HSG performed. Endometrial preparation for frozen embryo transfer will perform on the subsequence cycle |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipiodol® uterine treatment prior to IVF/ICSIAlso: Lipiodol® flushing prior to IVF/ICSILipiodol®, 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. | Procedure or surgery | Lipiodol® uterine treatment prior to IVF/ICSI |
Primary outcome
Live birth rate after the first transfer
Time frame: 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
34 secondary outcomes
Positive pregnancy test
Time frame: At 2 weeks after embryo(s) placement
Clinical pregnancy rate
Time frame: At 5 weeks after embryo(s) placement
Ongoing pregnancy rate
Time frame: At 10 weeks after embryo(s) placement
Multiple pregnancy
Time frame: At 7 weeks after embryo(s) placement
Cumulative live birth rate at 12 months after randomization
Time frame: At 12 months after randomization
Ectopic pregnancy rate
Time frame: At 12 weeks of gestation
Early miscarriage rate (Miscarriage <12 weeks)
Time frame: At 12 weeks of gestation
Late miscarriage rate (Miscarriage <22 weeks)
Time frame: At 22 weeks of gestation
Still birth rate
Time frame: After 22 weeks of gestation
Adverse events
Time frame: At delivery
Maternal thyroid function
Time frame: 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
Time frame: At 24-28 weeks of gestation
Hypertensive disorders of pregnancy rate
Time frame: From date of randomization until the date of first documented progression, assessed up to 12 months after randomization
Preterm birth rate
Time frame: At 22, 28, 32 and 37 weeks of gestation
Premature rupture of membranes rate
Time frame: At 37 weeks of gestation
Chorioamnionitis rate
Time frame: At delivery
Percentage of magnesium sulfate administration for neuroprotection
Time frame: At delivery
Antenatal corticosteroids for lung maturation
Time frame: At delivery
Administration of tocolytics agents
Time frame: At delivery
Birth weight
Time frame: At delivery
Large for gestational age
Time frame: At delivery
Small for gestational age
Time frame: At delivery
Gestational age at birth
Time frame: At delivery
Mode of delivery
Time frame: At delivery
Postpartum hemorrhage
Time frame: At delivery
Maternal death
Time frame: At delivery
Congenital anomalies
Time frame: Within 28 days of birth
Neonatal mortality
Time frame: Within 28 days of birth
neonatal intensive care unit (NICU) admission
Time frame: Within 28 days of birth
1-minute Apgar score
Time frame: At 1 minute after birth
5-minute Apgar score
Time frame: At 5 minute after birth
Low 5-minute Apgar score
Time frame: At 5 minute after birth
Neonatal thyroid function
Time frame: At delivery
Mode of conception
Time frame: From date of randomization until the date of pregnancy test or date of ultrasound, whichever came first, assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 23290741Thoma ME, McLain AC, Louis JF, King RB, Trumble AC, Sundaram R, Buck Louis GM. Prevalence of infertility in the United States as estimated by the current duration approach and a traditional constructed approach. Fertil Steril. 2013 Apr;99(5):1324-1331.e1. doi: 10.1016/j.fertnstert.2012.11.037. Epub 2013 Jan 3.
- Background: PubMed 24119894Abrao MS, Muzii L, Marana R. Anatomical causes of female infertility and their management. Int J Gynaecol Obstet. 2013 Dec;123 Suppl 2:S18-24. doi: 10.1016/j.ijgo.2013.09.008. Epub 2013 Sep 11.
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- Background: PubMed 15271870Johnson NP, Farquhar CM, Hadden WE, Suckling J, Yu Y, Sadler L. The FLUSH trial--flushing with lipiodol for unexplained (and endometriosis-related) subfertility by hysterosalpingography: a randomized trial. Hum Reprod. 2004 Sep;19(9):2043-51. doi: 10.1093/humrep/deh418. Epub 2004 Jul 22.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Lipiodol® uterine treatment prior to IVF/ICSI in people with IVF and Frozen Embryo Transfer, run by Mỹ Đức Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuong M Ho, MD ((+84) 903633377, tuongho.ivfmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate after the first transfer (time frame: At 22 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06563908, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.