Poor Response to Ovulation InductionNCT04485819
Optimal Embryonic Stage for Transfer in Poor Responders
An observational study of Poor Response to Ovulation Induction and Infertility, Female, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
A Prospective cohort study including couples with poor responder females who undergoing ICSI Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Poor Response to Ovulation Induction, Infertility, Female
- What is being tested?
- Cleavage stage transfer and Blast stage transfer
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Mar 2022
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Poor responders undergoing ICSI procedures at Ganin fertility center in Egypt
Who may be able to join
- poor responders females with AMH≤ 1.2ng and have ≤ 5 mature oocytes
- couples whose planning to do fresh transfer
- male partners have normal semen parameters according to WHO 2010.
Who cannot join
- sperm or oocyte donation
- gestational carriers
Trial locations and contacts
1 site in 1 country.
Amira Hassan, BSc. contact
About this study
Official title: Achieving Better Clinical Outcomes With Blastocyt Transfer in Poor Responders: a Prospective Study
A Prospective cohort study including couples with poor responder females who undergoing ICSI
Read the detailed description
Purpose:
To determine the optimal embryonic stage for transfer in poor responders.
Method:
Patients were divided into day 3 transfer group and day 5 transfer group. All cases had the same stimulation protocol and planning to do fresh embryo transfer. Assessments will be at Day 1, Day 3 and Day 5/6 according to Gardner's criteria 1999. Embryological and clinical data were recorded and then analyzed using SPSS (version 23) statistical software.
- Being tested
- Cleavage stage transfer, Blast stage transfer
- Keywords
- Poor responders, Embryo transfer, Cancellation rate, Implantation rate, Live birth rate
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleavage stage transferOther
transferring embryos through ICSI procedures for poor responders on cleavage stage of embryonic development.
Blast stage transferOther
transferring embryos through ICSI procedures for poor responders on blast stage of embryonic development.
| Study group | Role | What they receive |
|---|---|---|
| Cleavage stage transfer | Poor responders who transfer their embryos in cleavage stage on day 3 Receives: Other: Cleavage stage transfer | |
| Blast stage transfer | Poor responders who transfer their embryos on blast stage on day 5/6 Receives: Other: Blast stage transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
percentage of cycles started with the intent of egg retrieval that led to a live birth.
Measured: delivery of healthy neonate after 37 weeks of pregnancy
Implantation rate
Percentage of the implanted embryos number for each group / number of transferred embryos.
Measured: 6 weeks of pregnancy
Secondary outcomes (7)
Clinical pregnancy rate
Percentage of pregnant cases with fetal heart / transferred cases for each group
Measured: after 6 weeks of embryonic transfer
Cancellation rate
percentage of blast transfer cases who did not achieve blast stage (cancelled cases) / total number of blast stage cases
Measured: 5:6 days of ICSI
Fertilization rate
Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
Measured: 16:19 hours after intracytoplasmic injection(ICSI)
Cleavage rate
Percentage of cleaved embryos / Number of fertilized oocytes
Measured: 72 hours after ICSI
High quality day 3 embryos
High quality D3 embryos according to Gardner's criteria / total cleaved embryos
Measured: 72 hours after ICSI
Blast rate
Percentage of total blastocysts / Total cleaved embryos
Measured: 5:6 days of ICSI
High quality blast rate
Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos.
Measured: 5:6 days of ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jan 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Response to Ovulation InductionStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manar Hozyen, MSc., Principal investigator, Ganin Fertility CenterAmira Hassan, BSc., Principal investigator, Ganin Fertility CenterHanaa Elkhader, BSc., Principal investigator, Ganin Fertility CenterHosam Zaki, Study chair, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485819
- Sponsor's protocol ID
- MH0003
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Better Clinical Outcomes With Blastocyt Transfer in Poor Responders: a Prospective Study
- ClinicalTrials.gov ID
- NCT04485819
- Acronym / sponsor ID
- MH0003
- Keywords
- Poor responders, Embryo transfer, Cancellation rate, Implantation rate, Live birth rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 24 Jul 2020 (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.
A Prospective cohort study including couples with poor responder females who undergoing ICSI
Detailed description
Purpose:
To determine the optimal embryonic stage for transfer in poor responders.
Method:
Patients were divided into day 3 transfer group and day 5 transfer group. All cases had the same stimulation protocol and planning to do fresh embryo transfer. Assessments will be at Day 1, Day 3 and Day 5/6 according to Gardner's criteria 1999. Embryological and clinical data were recorded and then analyzed using SPSS (version 23) statistical software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cleavage stage transfer | – | Other: Cleavage stage transferPoor responders who transfer their embryos in cleavage stage on day 3 |
| Blast stage transfer | – | Other: Blast stage transferPoor responders who transfer their embryos on blast stage on day 5/6 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Poor responders undergoing ICSI procedures at Ganin fertility center in Egypt
Key inclusion criteria (3 listed)
- poor responders females with AMH≤ 1.2ng and have ≤ 5 mature oocytes
- couples whose planning to do fresh transfer
- male partners have normal semen parameters according to WHO 2010.
Key exclusion criteria (2 listed)
- sperm or oocyte donation
- gestational carriers
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 |
|---|---|---|
| Cleavage stage transfertransferring embryos through ICSI procedures for poor responders on cleavage stage of embryonic development. | Other | Cleavage stage transfer |
| Blast stage transfertransferring embryos through ICSI procedures for poor responders on blast stage of embryonic development. | Other | Blast stage transfer |
Primary outcome
Live birth rate
Time frame: delivery of healthy neonate after 37 weeks of pregnancy
percentage of cycles started with the intent of egg retrieval that led to a live birth.
Implantation rate
Time frame: 6 weeks of pregnancy
Percentage of the implanted embryos number for each group / number of transferred embryos.
7 secondary outcomes
Clinical pregnancy rate
Time frame: after 6 weeks of embryonic transfer
Cancellation rate
Time frame: 5:6 days of ICSI
Fertilization rate
Time frame: 16:19 hours after intracytoplasmic injection(ICSI)
Cleavage rate
Time frame: 72 hours after ICSI
High quality day 3 embryos
Time frame: 72 hours after ICSI
Blast rate
Time frame: 5:6 days of ICSI
High quality blast rate
Time frame: 5:6 days of ICSI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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Poor Response to Ovulation Induction, Infertility, Female
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.
Amira Hassan, BSc. contact
Manar Hozyen, MSc. principal investigator
Ganin Fertility Center
Amira Hassan, BSc. principal investigator
Ganin Fertility Center
Hanaa Elkhader, BSc. principal investigator
Ganin Fertility Center
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 Poor Response to Ovulation Induction and Infertility, Female, run by Ganin Fertility Center 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manar M Hozyen, MSc. (+2001229483320, manarnrc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: delivery of healthy neonate after 37 weeks of pregnancy). The study lists 2 primary outcomes in all. 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 24 Jul 2020; AzTrials last refreshed its copy on 31 Oct 2026.