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Completed

NCT Number: NCT05014867

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.

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Key information

Conditions

Embryo Transfer in Poor Responders

Age range

25 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Wael Elbanna Clinic

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Embryo transfer method

Procedure
  • 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

Primary outcomes

  1. ongoing pregnancy rate for poor responders women in the four arms

    Time frame: Till the end of 12 weeks of gestation

    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

Secondary outcomes

  1. miscarriage rate for poor responders women in the four arms

    Time frame: Till the end of 20 weeks of gestation

    Recording the following for the four arms of the study:

    • Occurance of abortion between week 7 and week 20 of gestation

  2. The baseline characteristics of the study participants

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

    Recording the following for the four arms of the study:

    -age , body mass index in kg/m^2

Sponsors and collaborators

Lead sponsor

Wael Elbanna Clinic

Other

Collaborators

  • National Research Centre, Egypt

Registry information

Official study title

A Prospective, Four Arms, Open Label, Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 20, 2021
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.