Mullerian Anomaly of UterusNCT03498079
Prevalence of Mullerian Anomalies in Infertile Women
An observational study of Mullerian Anomaly of Uterus, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Mullerian anomalies are congenital structural anomalies in the uterus . Its prevalence is not uncommon . Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mullerian Anomaly of Uterus
- What is being tested?
- 3D ultrasound
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2018to 25 Apr 2019
- How long will I take part?
- 4 Weeks
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: - females with age between 20-42 years with primary infertility
Who may be able to join
- females with age between 20-42 years with primary infertility
Who cannot join
- females with age above 42 years or below 20 years females with secondary infertility
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Prevalence of Mullerian Anomalies and PCO in Egyptian Women
- Mullerian anomalies are congenital structural anomalies in the uterus .
- Its prevalence is not uncommon .
Read the detailed description
- PCO is very common in gynecological practice
- Women with mullerian anomalies should be properly evaluated for other gynecological and urological problems
- Conditions
- Mullerian Anomaly of Uterus
- Being tested
- 3D ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D ultrasoundDiagnostic test
3D ultrasound will be done to females complaining from primary infertility with mullerian anomalies
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of participants who will prove to have PCO
diagnosis of PCO by US and by FSH and LH levels
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start16 Apr 2018
- Primary completion20 Apr 2019 (estimated)
- Study completion25 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mullerian Anomaly of UterusStudies 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
- 250 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital, National Research Centre, Egypt, misr Infertility centre ,Alaqsor
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498079
- Sponsor's protocol ID
- mullerian anomalies
- Status last verified
- Jan 2019
- First submitted
- 7 Apr 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will publish the results which will be obtained from this study
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Mullerian Anomalies and PCO in Egyptian Women
- ClinicalTrials.gov ID
- NCT03498079
- Acronym / sponsor ID
- mullerian anomalies
- Conditions
- Mullerian Anomaly of Uterus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital, National Research Centre, Egypt, misr Infertility centre ,Alaqsor
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 20 Apr 2019 (estimated)
- Study completion
- 25 Apr 2019 (estimated)
- First posted
- 13 Apr 2018 (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.
- Mullerian anomalies are congenital structural anomalies in the uterus .
- Its prevalence is not uncommon .
Detailed description
- PCO is very common in gynecological practice
- Women with mullerian anomalies should be properly evaluated for other gynecological and urological problems
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- - females with age between 20-42 years with primary infertility
Key inclusion criteria (1 listed)
- females with age between 20-42 years with primary infertility
Key exclusion criteria (1 listed)
- females with age above 42 years or below 20 years females with secondary infertility
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 |
|---|---|---|
| 3D ultrasound3D ultrasound will be done to females complaining from primary infertility with mullerian anomalies | Diagnostic test | – |
Primary outcome
the number of participants who will prove to have PCO
Time frame: within 4 weeks
diagnosis of PCO by US and by FSH and LH levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No. we will publish the results which will be obtained from this study
Related trials for Mullerian Anomaly of Uterus
RecruitingObservational study
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies
Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Vagina
RecruitingObservational study
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)
Mullerian Anomaly of Vagina, Mullerian Anomaly of Uterus, Nec
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
Algazeerah hospital -Location (Giza -Egypt ) and 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?
An observational study of Mullerian Anomaly of Uterus, 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 9 Jan 2019. 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 participants who will prove to have PCO (time frame: within 4 weeks). 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 9 Jan 2019.