Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563908
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Lipiodol Prior to FET LIFE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Lipiodol For Enhancing Live Birth Rates In Infertile Couples Undergoing In Vitro Fertilization Intracytoplasmic Sperm Injection A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIFE
Brief 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 IVFICSI 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 11 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 mgday 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
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 11 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 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None