Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05215119
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-01-18
Brief Title:
Immediate Versus Delayed Natural Cycle Frozen Embryo Transfers
Sponsor:
Antalya IVF
Organization:
Antalya IVF
Study Overview
Official Title:
Comparison of Immediate With Delayed Natural Cycle Frozen Embryo Transfers From Freeze-all-IVF Cycles a Randomized Control Trial of First Frozen Embryo Transfers
Status:
RECRUITING
Status Verified Date:
2024-01
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:
FET
Brief Summary:
Introduction
Based on recent studies the suggestion is that natural cycle frozen embryo transfers NC FET should preferably be used with evidence suggesting that artificial cycle FET AC FET is subject to increased risks of adverse obstetric and perinatal outcomes and possibly lower live birth rates There however is limited evidence on the most efficient and effective timing of NC FET following oocyte retrieval
Objective In this non-inferiority randomised controlled trial the effect on reproductive outcomes of NC FET performed immediately following the oocyte retrieval cycle ie after one menstruation will be investigated
Materials and Methods At a single IVF centre patients will be recruited from infertile patients presenting for freeze-all-IVF treatments Patients aged 18 to 30 years will be enrolled if they had 2 previous embryo transfers and had 1 blastocyst cryopreserved in their freeze-all cycles Enrolled patients N 800 will be randomised 11 to either the immediate group ie FET performed in the menstrual cycle immediately following the oocyte retrieval cycle or the delayed group ie FET performed in the menstrual cycle following two menstruations All FET will be performed in NC The primary outcome measure will be clinical pregnancy defined as the visual confirmation by transvaginal ultrasound scan of a gestational sac with normal heartbeat at 5 weeks of gestation The analyses will be performed according to per-procedure principles
Results The ovarian endometrial and time to transfer outcomes of the immediate group will be compared with those of the delayed group The clinical pregnancy rate of the immediate group will be compared with that of the delayed group
Based on recent studies the suggestion is that natural cycle frozen embryo transfers NC FET should preferably be used with evidence suggesting that artificial cycle FET AC FET is subject to increased risks of adverse obstetric and perinatal outcomes and possibly lower live birth rates There however is limited evidence on the most efficient and effective timing of NC FET following oocyte retrieval
Objective In this non-inferiority randomised controlled trial the effect on reproductive outcomes of NC FET performed immediately following the oocyte retrieval cycle ie after one menstruation will be investigated
Materials and Methods At a single IVF centre patients will be recruited from infertile patients presenting for freeze-all-IVF treatments Patients aged 18 to 30 years will be enrolled if they had 2 previous embryo transfers and had 1 blastocyst cryopreserved in their freeze-all cycles Enrolled patients N 800 will be randomised 11 to either the immediate group ie FET performed in the menstrual cycle immediately following the oocyte retrieval cycle or the delayed group ie FET performed in the menstrual cycle following two menstruations All FET will be performed in NC The primary outcome measure will be clinical pregnancy defined as the visual confirmation by transvaginal ultrasound scan of a gestational sac with normal heartbeat at 5 weeks of gestation The analyses will be performed according to per-procedure principles
Results The ovarian endometrial and time to transfer outcomes of the immediate group will be compared with those of the delayed group The clinical pregnancy rate of the immediate group will be compared with that of the delayed group
Detailed Description:
Introduction The increasing success of frozen embryo transfers FET in assisted reproductive technology ART and therefore the increasing use of FET to overcome standard IVF complications ie adverse ovarian stimulation iatrogenesis and intra-cycle discovery of intrauterine abnormalities and to facilitate the use of modified IVF treatment ie pre-implantation genetic testing and luteal ovarian stimulation has highlighted disadvantages inherent to FET The major concern is the evidence that FET pregnancies are subject to adverse obstetric and perinatal outcomes such as placental and hypertensive complications large for gestational age infants increased pregnancy loss increased preterm delivery Moreover the presumed benefits of more physiological endometria in FET demands further research into the origins of the adverse obstetric and perinatal outcomes and the elimination of their causes
Endometrial preparation methods in FET can be divided into two major groups artificial AC and natural cycle NC methods While the initial studies comparing endometrial preparation methods for FET and confirmed by study reviews and meta-analyses showed that no one method was superior in terms of reproductive outcomes recent studies have shown that the NC cycle method results in reduced adverse obstetric and perinatal outcome rates and increased live birth rates There is increasing evidence and understanding that using the AC method significantly increases the risks of adverse obstetric and perinatal outcomes because of the absence of a functional corpus luteum CL In addition to the production of hormones ie estrogen and progesterone CL also produces vasoactive molecules ie relaxin vascular endothelial growth factor essential for optimal vascular developments in early pregnancy ie implantation and placentation Based on recent studies the suggestion therefore is that clinicians should preferably use NC FET Further research however may be required to confirm the most optimal endometrial preparation and timing ie embryo and endometrial synchrony method for FET because suggested preference is still being based on poor-quality evidence
There is limited evidence on the most efficient and effective timing of NC FET following oocyte retrieval ie the cycle subject to ovarian stimulation as nearly all previous studies included the investigation of mostly AC FET These studies at most confirmed that reproductive outcomes were not disadvantaged if FET were performed immediately following the oocyte retrieval cycle Therefore suggesting that ovarian stimulation ie supraphysiological hormone levels had no spill-over effects on endometrial and ovarian function in subsequent menstrual cycles even in the cycle immediately following oocyte retrieval Not having an extended delay to FET is considered by most patients to be less stressful and by clinicians to be more efficient In this non-inferiority randomised controlled trial the effect on reproductive outcomes of NC FET performed in menstrual cycles immediately following the oocyte retrieval cycle will be investigated
Endometrial preparation methods in FET can be divided into two major groups artificial AC and natural cycle NC methods While the initial studies comparing endometrial preparation methods for FET and confirmed by study reviews and meta-analyses showed that no one method was superior in terms of reproductive outcomes recent studies have shown that the NC cycle method results in reduced adverse obstetric and perinatal outcome rates and increased live birth rates There is increasing evidence and understanding that using the AC method significantly increases the risks of adverse obstetric and perinatal outcomes because of the absence of a functional corpus luteum CL In addition to the production of hormones ie estrogen and progesterone CL also produces vasoactive molecules ie relaxin vascular endothelial growth factor essential for optimal vascular developments in early pregnancy ie implantation and placentation Based on recent studies the suggestion therefore is that clinicians should preferably use NC FET Further research however may be required to confirm the most optimal endometrial preparation and timing ie embryo and endometrial synchrony method for FET because suggested preference is still being based on poor-quality evidence
There is limited evidence on the most efficient and effective timing of NC FET following oocyte retrieval ie the cycle subject to ovarian stimulation as nearly all previous studies included the investigation of mostly AC FET These studies at most confirmed that reproductive outcomes were not disadvantaged if FET were performed immediately following the oocyte retrieval cycle Therefore suggesting that ovarian stimulation ie supraphysiological hormone levels had no spill-over effects on endometrial and ovarian function in subsequent menstrual cycles even in the cycle immediately following oocyte retrieval Not having an extended delay to FET is considered by most patients to be less stressful and by clinicians to be more efficient In this non-inferiority randomised controlled trial the effect on reproductive outcomes of NC FET performed in menstrual cycles immediately following the oocyte retrieval cycle will be investigated
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