InfertilityNCT04778319
Hysterosalpingography and Hysteroscopy in ICSI
A study testing occlusion of tubes and non occlusion of tubes in people with Infertility, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
unexplained infertility is a rising problem in clinical practice Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- occlusion of tubes and non occlusion of tubes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2021to 15 Feb 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- women with infertility
Who cannot join
- women with medical disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Aljazeera( Al Gazeera) hospital
Giza
Mahmoud Alalfy, PhD, +201002611058 ext. +2, mahmoudalalfy@ymail.com
About this study
Official title: Hysterosalpingography and Hysteroscopy in Intracytoplasmic Sperm Injection
unexplained infertility is a rising problem in clinical practice
Read the detailed description
Assessment of uterine cavity is very important before ICSI
- Conditions
- Infertility
- Being tested
- occlusion of tubes, non occlusion of tubes
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusion of tubesOther
to occlude the fallopian tubes
non occlusion of tubesOther
not to occlude the tubes
| Study group | Role | What they receive |
|---|---|---|
| tubal occlusion | Active comparator | occlusion of tubes Receives: Other: occlusion of tubes |
| non occlusion of tube | Sham comparator | non occlusion of tubes Receives: Other: non occlusion of tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of women who will become pregnant
number of women who will have positive pregnancy test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start2 Mar 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion15 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, Principal investigator, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778319
- Sponsor's protocol ID
- tubal disease
- Status last verified
- Feb 2021
- First submitted
- 27 Feb 2021
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysterosalpingography and Hysteroscopy in Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT04778319
- Acronym / sponsor ID
- tubal disease
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 2 Mar 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 3 Mar 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.
unexplained infertility is a rising problem in clinical practice
Detailed description
Assessment of uterine cavity is very important before ICSI
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tubal occlusion | Active comparator | Other: occlusion of tubesocclusion of tubes |
| non occlusion of tube | Sham comparator | Other: non occlusion of tubesnon occlusion of tubes |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with infertility
Key exclusion criteria (1 listed)
- women 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 |
|---|---|---|
| occlusion of tubesto occlude the fallopian tubes | Other | tubal occlusion |
| non occlusion of tubesnot to occlude the tubes | Other | non occlusion of tube |
Primary outcome
the number of women who will become pregnant
Time frame: 3 months
number of women who will have positive pregnancy test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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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.
Mahmoud Alalfy principal investigator
Algezeera hospitaland National Research Centre ,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occlusion of tubes and non occlusion of tubes in people with 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 3 Mar 2021. 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. Some participants in this study may receive a placebo. 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 become pregnant (time frame: 3 months). 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 3 Mar 2021; AzTrials last refreshed its copy on 2 Nov 2026.