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

Wael Elbanna Clinic

Status: Completed

Conditions: Embryo Transfer in Poor Responders

Treatments: Procedure: Embryo transfer method

Study type: Observational

Funder types: Other

Identifiers

NCT05014867

Elbanna_003

Details and patient eligibility

About

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.

Full 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

Enrollment: 291 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

291 participants in 4 patient groups

Arm 1

Description:

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

Treatment:

Procedure: Embryo transfer method

Arm 2

Description:

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

Treatment:

Procedure: Embryo transfer method

Arm 3

Description:

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

Treatment:

Procedure: Embryo transfer method

Arm 4

Description:

Poor responders women undergoing conventional frozen embryo transfer on Day 5

Treatment:

Procedure: Embryo transfer method