Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304792
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-02-23
Brief Title:
Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer a Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this randomized controlled trial is to examine whether single blastocyst transfer in the first cycle after oocyte retrieval immediate is non-inferior to single blastocyst transfer in a subsequent cycle postponed in stimulated or programmed cycle frozen embryo transfer FET The primary outcome is live birth rate
Detailed Description:
This is a multicenter randomized controlled trial with the aim of investigating if FET in the first cycle after oocyte retrieval immediate is non-inferior to the standard treatment where FET is postponed to a subsequent cycle
Patient inclusion is set to begin in February 2024 and continue til August 2028 A total of 484 patients will be included according to the inclusion and exclusion criteria
Patients will be randomized 11 to either immediate or postponed FET Randomization is stratified for stimulated FET with letrozole stimulated FET with gonadotropins and programmed FET estradiol and progesterone treatment
The study groups will be
1 FET immediate Programmed cycle PC or Stimulated cycle SC FET in the first cycle after oocyte retrieval and fresh embryo transfer or freeze-all
2 FET postponed PC or SC FET after at least one cycle following oocyte retrieval and fresh embryo transfer or freeze-all
Participants will have a visit on cycle day 2-4 of the first period after oocyte retrieval where baseline characteristics will be assessed Patients start treatment according to the randomization thus women in the FET immediate group will start FET immediately whereas women randomized to postponed FET will wait for at least one cycle natural or induced by sequential estradiol-Provera treatment in oligo-anovulatory women
SC-FET Patients undergoing stimulated cycle FET will start the mild ovarian stimulation with either letrozole 5 mg 25 daily for five days starting on cd 3-5 or with gonadotropins hMGrFSH 50-75 IE daily initial dose may be higher if needed based on previous treatments Ovulation trigger hCG are administered when the leading follicle reaches 18 mm letrozole or 17 mm gonadotropin Blastocyst transfer will be performed 6-7 days after trigger
PC-FET Patients undergoing PC FET will start treatment with estradiol 6 mgday from cycle day 3-5 and after 10-12 days an ultrasound scan will be performed If the endometrial thickness is 7 mm plasma levels of estradiol can be measured and additional estradiol is added according to local clinical practice After another 4-6 days a new ultrasound scan is performed and progesterone supplementation will be added no matter of the endometrial thickness and blastocyst transfer will be performed on the 5th or the 6th day of progesterone supplementation
Blood samples will be drawn on the baseline visit all patients on cycle day 2-4 in the postponed FET group on the day of hCG trigger SC or on progesterone supplementation day 10-12 PC on the day the blastocyst transfer and on the day of pregnancy testing
In case of pregnancy pregnancy and delivery data will be collected from the patients medical records and the new borns birth record This will be done in accordance to an informed consent form which is signed by the participants at inclusion
The primary outcome of the study will be live birth rates LBR Secondary outcomes include 1 LBR per blastocyst transfer 2 Clinical pregnancy rate CPR 3 ongoing pregnancy rate OPR 4 miscarriage rate MR 5 cancelled cycle rate including reason for cycle cancellation 6 endocrinology of the luteal phase by means of hormone levels at predefined time-points 7 number of ovarian follicular structures 10 mm at cycle day 2-5 of the treatment cycle and on the first day of progesterone supplementation 8 time to pregnancy and live birth from start of ovarian stimulation in the fresh cycle
Pregnancy related complications such as preeclampsia pregnancy related hypertension medically assisted delivery and postpartum hemorrhage 100 mL and neonatal outcomes including preterm birth low birth weight small or large for gestational age and perinatal mortality will also be assessed and compared between groups
An interim analysis will be performed after inclusion of the first 150 patients n75 in each group The mean number of scans will be compared between the two groups This will be done to evaluate if the mean number of ultrasoundsscans in the intervention group exceeds that of the control group by more than two scans if this is the case we will consider terminating the trial
Patient inclusion is set to begin in February 2024 and continue til August 2028 A total of 484 patients will be included according to the inclusion and exclusion criteria
Patients will be randomized 11 to either immediate or postponed FET Randomization is stratified for stimulated FET with letrozole stimulated FET with gonadotropins and programmed FET estradiol and progesterone treatment
The study groups will be
1 FET immediate Programmed cycle PC or Stimulated cycle SC FET in the first cycle after oocyte retrieval and fresh embryo transfer or freeze-all
2 FET postponed PC or SC FET after at least one cycle following oocyte retrieval and fresh embryo transfer or freeze-all
Participants will have a visit on cycle day 2-4 of the first period after oocyte retrieval where baseline characteristics will be assessed Patients start treatment according to the randomization thus women in the FET immediate group will start FET immediately whereas women randomized to postponed FET will wait for at least one cycle natural or induced by sequential estradiol-Provera treatment in oligo-anovulatory women
SC-FET Patients undergoing stimulated cycle FET will start the mild ovarian stimulation with either letrozole 5 mg 25 daily for five days starting on cd 3-5 or with gonadotropins hMGrFSH 50-75 IE daily initial dose may be higher if needed based on previous treatments Ovulation trigger hCG are administered when the leading follicle reaches 18 mm letrozole or 17 mm gonadotropin Blastocyst transfer will be performed 6-7 days after trigger
PC-FET Patients undergoing PC FET will start treatment with estradiol 6 mgday from cycle day 3-5 and after 10-12 days an ultrasound scan will be performed If the endometrial thickness is 7 mm plasma levels of estradiol can be measured and additional estradiol is added according to local clinical practice After another 4-6 days a new ultrasound scan is performed and progesterone supplementation will be added no matter of the endometrial thickness and blastocyst transfer will be performed on the 5th or the 6th day of progesterone supplementation
Blood samples will be drawn on the baseline visit all patients on cycle day 2-4 in the postponed FET group on the day of hCG trigger SC or on progesterone supplementation day 10-12 PC on the day the blastocyst transfer and on the day of pregnancy testing
In case of pregnancy pregnancy and delivery data will be collected from the patients medical records and the new borns birth record This will be done in accordance to an informed consent form which is signed by the participants at inclusion
The primary outcome of the study will be live birth rates LBR Secondary outcomes include 1 LBR per blastocyst transfer 2 Clinical pregnancy rate CPR 3 ongoing pregnancy rate OPR 4 miscarriage rate MR 5 cancelled cycle rate including reason for cycle cancellation 6 endocrinology of the luteal phase by means of hormone levels at predefined time-points 7 number of ovarian follicular structures 10 mm at cycle day 2-5 of the treatment cycle and on the first day of progesterone supplementation 8 time to pregnancy and live birth from start of ovarian stimulation in the fresh cycle
Pregnancy related complications such as preeclampsia pregnancy related hypertension medically assisted delivery and postpartum hemorrhage 100 mL and neonatal outcomes including preterm birth low birth weight small or large for gestational age and perinatal mortality will also be assessed and compared between groups
An interim analysis will be performed after inclusion of the first 150 patients n75 in each group The mean number of scans will be compared between the two groups This will be done to evaluate if the mean number of ultrasoundsscans in the intervention group exceeds that of the control group by more than two scans if this is the case we will consider terminating the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None