Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05716139
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2023-01-21
Brief Title:
Natural Cycle vs Programmed Cycle Frozen Embryo Transfer
Sponsor:
Indira IVF Hospital Pvt Ltd
Organization:
Indira IVF Hospital Pvt Ltd
Study Overview
Official Title:
Preeclampsia Following Natural vs Artificial Cycle Frozen Embryo Transfer
Status:
RECRUITING
Status Verified Date:
2023-07
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 goal of this type of study randomized controlled trialis to compare Preeclampsia following Natural vs Artificial Cycle in patients undergoing frozen embryo transfer
The main questions it aims to answer is
Does NC-FET decreases the incidence of preeclampsia in patients undergoing frozen embryo transfer as compared to AC-FET
The main objective is to compare the proportion of preeclampsia in women with a viable pregnancy with natural cycle protocol to artificial cycle protocol when practicing frozen embryo transfer Participants recruited will be divided into two ARM1513 per arm ARM 1 will undergo the Natural Cycle procedure of Embryo transfer and ARM 2 will undergo the Artificial Cycle procedure of Embryo transfer The primary outcome will be the proportion of preeclampsia The duration of the study is around 2 year
The main questions it aims to answer is
Does NC-FET decreases the incidence of preeclampsia in patients undergoing frozen embryo transfer as compared to AC-FET
The main objective is to compare the proportion of preeclampsia in women with a viable pregnancy with natural cycle protocol to artificial cycle protocol when practicing frozen embryo transfer Participants recruited will be divided into two ARM1513 per arm ARM 1 will undergo the Natural Cycle procedure of Embryo transfer and ARM 2 will undergo the Artificial Cycle procedure of Embryo transfer The primary outcome will be the proportion of preeclampsia The duration of the study is around 2 year
Detailed Description:
The Research questionPICO addressed is Does NC-FET decreases the incidence of preeclampsia in patients undergoing frozen embryo transfer as compared to AC-FET The hypothesis taken is NC-FET will decrease the incidence of preeclampsia compared to AC-FET The sample size is taken as 3026 1513 per arm The Primary Objective is to compare the proportion of preeclampsia in women with a viable pregnancy with natural cycle protocol to artificial cycle protocol when practicing frozen embryo transfer The study outcome of the proportion of preeclampsia after 20 weeks of gestation or 6 weeks post-delivery There are two arms-Arm 1 Active Comparator Natural Cycle and Arm 2 control Artificial Cycle FET The Randomization is done through Random Allocation as per computer generated sequence The Blindingmasking is done Open labeled The Study Duration is from Feb 2023 to Jan 2025 Participation Duration is 10 months
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?:
False
Is an FDA AA801 Violation?:
None