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

NCT05014867 | Completed

• 1 other identifier: Elbanna_003
• Study Type: observational
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Embryo Transfer in Poor Responders

Keywords

Poor responders; PGS; Sequential; Embryo transfer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• miscarriage rate for poor responders women in the four arms

  Till the end of 20 weeks of gestation

• The baseline characteristics of the study participants

  Before study intervention of the four arms (at day 2 in the ovulation induction cycle)

Study Arms (4)

Arm 1

Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5

Procedure: Embryo transfer method

Arm 2

Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5

Procedure: Embryo transfer method

Arm 3

Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS

Procedure: Embryo transfer method

Arm 4

Poor responders women undergoing conventional frozen embryo transfer on Day 5

Procedure: Embryo transfer method

Interventions

Embryo transfer method PROCEDURE

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

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• Patients with any immunological disorders
• Patients with uncontrolled systemic diseases
• Patients with previous uterine surgeries except for Cesarean section

Sponsors & Collaborators

• Wael Elbanna Clinic: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

Wael Elbanna Clinic

Cairo, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing director for Wael Elbanna Clinic

Study Record Dates

• First Submitted: August 14, 2021
• First Posted: August 20, 2021
• Study Start: September 10, 2021
• Primary Completion: October 20, 2023
• Study Completion: November 12, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

EG (1)