NCT05014867

Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols

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
• Phase: —
• Study type: Observational
• Enrollment: 291 (actual)
• Sponsor: Wael Elbanna Clinic · Academic / Other
• Sex: Female
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Embryo Transfer in Poor Responders

Interventions

Type	Name	Description
PROCEDURE	Embryo transfer method	1. Sequential embryo transfer on day 3 and day 5 in a frozen cycle 2. Sequential embryo transfer on day 3 and day 5 in a fresh cycle 3. Sequential embryo transfer on day 3 and day 5 after performing PGS 4. Conventional Day 5 frozen embryo transfer

Timeline

• Start date: 2021-09-10
• Primary completion: 2023-10-20
• Completion: 2024-11-12
• First posted: 2021-08-20
• Last updated: 2025-07-28

Locations

1 site across 1 country: Egypt