InfertilityNCT05004922
Site of Embryo Transfer in Intracytoplasmic Sperm Injection
An observational study of Infertility, run by National Research Centre, Egypt.
Trial summary
The technique of embryo transfer is thought to affect the implantation and pregnancy rate .At present, the implantation site can be estimated from the location of the very early gestational sac by transvaginal ultrasound. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Embryo transfer into upper cavity and Embryo transfer into midcavity
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Feb 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: infertile women
Who may be able to join
- 1- AVF uterus. 2- BMI less than 30
Who cannot join
- 1- RVF uterus. 2- BMI more than 30.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Correlation Between the Site of Embryo Transfer and the Site of Gestational Sac and Placental Implantation
The technique of embryo transfer is thought to affect the implantation and pregnancy rate .At present, the implantation site can be estimated from the location of the very early gestational sac by transvaginal ultrasound.
Read the detailed description
Many authors claimed that an increase in implantation and pregnancy rates has been reported to occur when embryos are transferred to the central area of the uterine cavity but there are no studies about the implantation site after using this type of transfer.
- Conditions
- Infertility
- Being tested
- Embryo transfer into upper cavity, Embryo transfer into midcavity
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo transfer into upper cavityOther
Also called Gestational sac site after embryo transfer
Transfer of embryos in upper cavity
Embryo transfer into midcavityOther
Also called Gestational sac site after embryo transfer
Transfer of embryos in mid cavity
| Study group | Role | What they receive |
|---|---|---|
| ICSI in upper cavity | Embryo transfer into the upper cavity Receives: Other: Embryo transfer into upper cavity | |
| ICSI in midcavity | Embryo transfer into the midcavity Receives: Other: Embryo transfer into midcavity |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of women who will get pregnant in each group
how many women will get pregnant after ICSI in every group
Measured: within one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Elsirgany, National Research Centre, Egypt
- Investigators
- Sherif Elsirgany, M.D, Principal investigator, Researcher, Family planning and Reproductive Health Department, NRC, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004922
- Sponsor's protocol ID
- ICSI
- Status last verified
- Aug 2021
- First submitted
- 3 Feb 2019
- Last updated
- 13 Aug 2021
- 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 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between the Site of Embryo Transfer and the Site of Gestational Sac and Placental Implantation
- ClinicalTrials.gov ID
- NCT05004922
- Acronym / sponsor ID
- ICSI
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 13 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.
The technique of embryo transfer is thought to affect the implantation and pregnancy rate .At present, the implantation site can be estimated from the location of the very early gestational sac by transvaginal ultrasound.
Detailed description
Many authors claimed that an increase in implantation and pregnancy rates has been reported to occur when embryos are transferred to the central area of the uterine cavity but there are no studies about the implantation site after using this type of transfer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICSI in upper cavity | – | Other: Embryo transfer into upper cavityEmbryo transfer into the upper cavity |
| ICSI in midcavity | – | Other: Embryo transfer into midcavityEmbryo transfer into the midcavity |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- infertile women
Key inclusion criteria (1 listed)
- 1- AVF uterus. 2- BMI less than 30
Key exclusion criteria (1 listed)
- 1- RVF uterus. 2- BMI more than 30.
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 into upper cavityAlso: Gestational sac site after embryo transferTransfer of embryos in upper cavity | Other | ICSI in upper cavity |
| Embryo transfer into midcavityAlso: Gestational sac site after embryo transferTransfer of embryos in mid cavity | Other | ICSI in midcavity |
Primary outcome
number of women who will get pregnant in each group
Time frame: within one month
how many women will get pregnant after ICSI in every group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Sherif Elsirgany, M.D principal investigator
Researcher, Family planning and Reproductive Health Department, NRC, Egypt
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by National Research Centre, 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 1 inclusion and 1 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 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Sherif Elsirgany, M.D (+201223607191, sherifelsirgany@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of women who will get pregnant in each group (time frame: within one month). 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 13 Aug 2021.