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

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.

Study Overview

• Status: Completed
• Conditions: Embryo Transfer in Poor Responders
• Intervention / Treatment: Procedure: Embryo transfer method

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

• Study Type: Observational
• Enrollment (Actual): 291

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Wael Elbanna Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Poor responders women undergoing one of the following:

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

Description

Inclusion Criteria:

1. The age group of these women is 25-45 years
2. Normal endometrial cavity confirmed by hysteroscopy
3. Poor responders with AMH <1
4. Patients with at least grade 1 days 3 embryo and grade 1 day 5 frozen embryos

Exclusion Criteria:

1. Patients with any immunological disorders
2. Patients with uncontrolled systemic diseases
3. Patients with previous uterine surgeries except for Cesarean section

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1; Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5	Procedure: Embryo transfer method; Sequential embryo transfer on day 3 and day 5 in a frozen cycle; Sequential embryo transfer on day 3 and day 5 in a fresh cycle; Sequential embryo transfer on day 3 and day 5 after performing PGS; Conventional Day 5 frozen embryo transfer
Arm 2; Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5	Procedure: Embryo transfer method; Sequential embryo transfer on day 3 and day 5 in a frozen cycle; Sequential embryo transfer on day 3 and day 5 in a fresh cycle; Sequential embryo transfer on day 3 and day 5 after performing PGS; Conventional Day 5 frozen embryo transfer
Arm 3; Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS	Procedure: Embryo transfer method; Sequential embryo transfer on day 3 and day 5 in a frozen cycle; Sequential embryo transfer on day 3 and day 5 in a fresh cycle; Sequential embryo transfer on day 3 and day 5 after performing PGS; Conventional Day 5 frozen embryo transfer
Arm 4; Poor responders women undergoing conventional frozen embryo transfer on Day 5	Procedure: Embryo transfer method; Sequential embryo transfer on day 3 and day 5 in a frozen cycle; Sequential embryo transfer on day 3 and day 5 in a fresh cycle; Sequential embryo transfer on day 3 and day 5 after performing PGS; Conventional Day 5 frozen embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ongoing pregnancy rate for poor responders women in the four arms	Recording the following for the four arms of the study: Presence of intrauterine gestational sac at 12 weeks beyond embryo transfer; Presence of fetal heart pulsation at 12 weeks beyond embryo transfer	Till the end of 12 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
miscarriage rate for poor responders women in the four arms	Recording the following for the four arms of the study: - Occurance of abortion between week 7 and week 20 of gestation	Till the end of 20 weeks of gestation
The baseline characteristics of the study participants	Recording the following for the four arms of the study: -age , body mass index in kg/m^2	Before study intervention of the four arms (at day 2 in the ovulation induction cycle)

Collaborators and Investigators

• Sponsor: Wael Elbanna Clinic
• Collaborators: National Research Centre, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): October 20, 2023
• Study Completion (Actual): November 12, 2024

Study Registration Dates

• First Submitted: August 14, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Embryo transfer; Poor responders; PGS; Sequential
• Other Study ID Numbers: Elbanna_003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No