Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-01 @ 5:32 AM
Study NCT ID:
NCT05014867
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2021-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols
Sponsor:
Wael Elbanna Clinic
Organization:
Study Overview
Official Title:
A Prospective, Four Arms, Open Label, Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols
Status:
COMPLETED
Status Verified Date:
2025-07
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:
Published data on sequential transfer are limited and are not consistent. Also, further research into methods of risk combination and assessment, would allow us to help our patients make better-informed decisions about whether or not to proceed with invasive diagnostic tests as the PGS. So our study aims to describe the ongoing pregnancy rate for poor responders women undergoing four different embryo transfer protocols among four arms within the study. Moreover, to describe the miscarriage rate, and the baseline characteristics for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.
Detailed Description:
The study aims to describe the ongoing pregnancy rate for poor responders women undergoing four different embryo transfer protocols among four arms within the study. Moreover, to describe the miscarriage rate, and the baseline characteristics for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.
This study is prospective, comparative, open label and multi-center study. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants.
The study materials that will be used will include blood tests, and ultrasound. The study will involve four study arms:
Arm 1: Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5 Arm 2: Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5 Arm 3: Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS Arm 4: Poor responders women undergoing conventional frozen embryo transfer on Day 5
Primary and secondary key measurements will be used in the study.
The primary measures will include:
* Presence of intrauterine gestational sac at 12 weeks beyond embryo transfer
* Presence of fetal heart pulsation at 12 weeks beyond embryo transfer
The secondary key measures will include:
* Occurance of abortion between week 7 and week 20 of gestation
* Recording the the baseline characteristics of the study participants
This study is prospective, comparative, open label and multi-center study. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants.
The study materials that will be used will include blood tests, and ultrasound. The study will involve four study arms:
Arm 1: Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5 Arm 2: Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5 Arm 3: Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS Arm 4: Poor responders women undergoing conventional frozen embryo transfer on Day 5
Primary and secondary key measurements will be used in the study.
The primary measures will include:
* Presence of intrauterine gestational sac at 12 weeks beyond embryo transfer
* Presence of fetal heart pulsation at 12 weeks beyond embryo transfer
The secondary key measures will include:
* Occurance of abortion between week 7 and week 20 of gestation
* Recording the the baseline characteristics of the study participants
Study Oversight
Has Oversight DMC:
False
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?: