InfertilityNCT04257708
Cavity Evaluation Before Intracytoplasmic Sperm Injection
An observational study of Infertility, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Uterine cavity evaluation is an integral part of assessment Of women for ICSI Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- ultrasound
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Feb 2020to 10 Jan 2021
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with infertility
Who may be able to join
- women with infertility more than one year
Who cannot join
- 2omen with medical disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Cavity Evaluation Before Intracytoplasmic Sperm Injection in Women With Infertility
Uterine cavity evaluation is an integral part of assessment Of women for ICSI
Read the detailed description
Transvaginal us is the main role in this aspect
- Conditions
- Infertility
- Being tested
- ultrasound
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
Transvaginal us to assess the cavity
| Study group | Role | What they receive |
|---|---|---|
| normal uterine cavity | Not described Receives: Diagnostic Test: ultrasound | |
| abnormal uterine cavity | Not described Receives: Diagnostic Test: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will has positive pregnancy test
The women who will got pregnant
Measured: within a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start9 Feb 2020 (estimated)
- Primary completion10 Nov 2020 (estimated)
- Study completion10 Jan 2021 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Study chair, Algezeera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257708
- Sponsor's protocol ID
- Uterus
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cavity Evaluation Before Intracytoplasmic Sperm Injection in Women With Infertility
- ClinicalTrials.gov ID
- NCT04257708
- Acronym / sponsor ID
- Uterus
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 9 Feb 2020 (estimated)
- Primary completion
- 10 Nov 2020 (estimated)
- Study completion
- 10 Jan 2021 (estimated)
- First posted
- 6 Feb 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.
Uterine cavity evaluation is an integral part of assessment Of women for ICSI
Detailed description
Transvaginal us is the main role in this aspect
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal uterine cavity | – | Diagnostic Test: ultrasound |
| abnormal uterine cavity | – | Diagnostic Test: ultrasound |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with infertility
Key inclusion criteria (1 listed)
- women with infertility more than one year
Key exclusion criteria (1 listed)
- 2omen with medical disorders
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 |
|---|---|---|
| ultrasoundTransvaginal us to assess the cavity | Diagnostic test | abnormal uterine cavity, normal uterine cavity |
Primary outcome
The number of women who will has positive pregnancy test
Time frame: within a year
The women who will got pregnant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
Related trials for Infertility
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
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.
Mahmoud Alalfy, PhD study chair
Algezeera
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 Infertility, run by Aljazeera Hospital 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 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 6 Feb 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 Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women who will has positive pregnancy test (time frame: within a year). 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 6 Feb 2020.