Embryo Transfer in Poor RespondersNCT05014867
Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols
An observational study of Embryo Transfer in Poor Responders, run by Wael Elbanna Clinic at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Embryo Transfer in Poor Responders
- What is being tested?
- Embryo transfer method
- Type of treatment
- Surgery or procedure
- How many people
- 291 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2021to 12 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- Patients with any immunological disorders
- Patients with uncontrolled systemic diseases
- Patients with previous uterine surgeries except for Cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Embryo transfer method
- Keywords
- Poor responders, PGS, Sequential, Embryo transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo transfer methodProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5 Receives: Procedure: Embryo transfer method | |
| Arm 2 | Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5 Receives: Procedure: Embryo transfer method | |
| Arm 3 | Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS Receives: Procedure: Embryo transfer method | |
| Arm 4 | Poor responders women undergoing conventional frozen embryo transfer on Day 5 Receives: Procedure: Embryo transfer method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Till the end of 12 weeks of gestation
Secondary outcomes (2)
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
Measured: 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
Measured: Before study intervention of the four arms (at day 2 in the ovulation induction cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start10 Sep 2021
- Primary completion20 Oct 2023
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo Transfer in Poor RespondersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wael Elbanna Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Principal investigator, Wael Elbanna, Wael Elbanna Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014867
- Sponsor's protocol ID
- Elbanna_003
- Status last verified
- Jul 2025
- First submitted
- 14 Aug 2021
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Four Arms, Open Label, Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols
- ClinicalTrials.gov ID
- NCT05014867
- Acronym / sponsor ID
- Elbanna_003
- Conditions
- Embryo Transfer in Poor Responders
- Keywords
- Poor responders, PGS, Sequential, Embryo transfer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Wael Elbanna ClinicUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Procedure: Embryo transfer methodPoor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5 |
| Arm 2 | – | Procedure: Embryo transfer methodPoor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5 |
| Arm 3 | – | Procedure: Embryo transfer methodPoor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS |
| Arm 4 | – | Procedure: Embryo transfer methodPoor responders women undergoing conventional frozen embryo transfer on Day 5 |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with any immunological disorders
- Patients with uncontrolled systemic diseases
- Patients with previous uterine surgeries except for Cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embryo transfer method1. 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 | Procedure or surgery | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
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
2 secondary outcomes
miscarriage rate for poor responders women in the four arms
Time frame: Till the end of 20 weeks of gestation
The baseline characteristics of the study participants
Time frame: Before study intervention of the four arms (at day 2 in the ovulation induction cycle)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embryo Transfer in Poor Responders, run by Wael Elbanna Clinic at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ongoing pregnancy rate for poor responders women in the four arms (time frame: Till the end of 12 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.