Unexplained InfertilityPhase 4NCT04754243
New Protocol in Unexplained Infertility
A Phase 4 study testing Gonadotropin and Standard protocol in IUI in people with Unexplained Infertility, run by Tanta University at 1 site in Egypt.
Trial summary
The new protocol ANTIUI provides good results regarding ovulation and pregnancy rates in patients with unexplained infertility Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- Gonadotropin and Standard protocol in IUI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 31 Dec 2024
- Phase
- Phase 4
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unexplained infertility
- Duration less than 5 years
- Good ovarian reserve AMH> 1.1
- Normal patent tubes
- No previous trials of IUI with the same protocol
Who cannot join
- Age > 35 years
- Duration of infertility> 5 years
- Abnormal semen
- Hypoplastic tubes
- prior failed ICSI
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ayman Shehata Dawood
Tanta, Gharbia Governorate, 31111
Ayman Dawood, MD, +201020972067, ayman.dawood@med.tanta.edu.eg
About this study
Official title: A Higher Ovulation and Pregnancy Rates in Patients With Unexplained Infertility After Application of ANTIUI Protocol: A Randomized Multicenter Controlled Study
The new protocol ANTIUI provides good results regarding ovulation and pregnancy rates in patients with unexplained infertility
Read the detailed description
Patients with unexplained infertility has normal investigations regarding hormonal, structural data. Semen is normal but no pregnancy occurs.
Before trying ICSI, we could help these patients with ANTIUI
- Conditions
- Unexplained Infertility
- Being tested
- Gonadotropin, Standard protocol in IUI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GonadotropinDrug
Giving patients gonadotropins and antagonist cetrotide
Standard protocol in IUIDrug
Giving patients gonadotropins without antagonist cetrotide
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Will receive ANTIUI protocol Receives: Drug: Gonadotropin |
| Control group | Active comparator | Will receive standard protocol in IUI and unexplained infertility Receives: Drug: Standard protocol in IUI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation
Disappearance of mature follicle
Measured: 6 months
Pregnancy
Number of pregnant cases
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel groups each is receiving different intervention
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754243
- Sponsor's protocol ID
- ANTIUI
- Status last verified
- Jul 2023
- First submitted
- 10 Feb 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Within 6 MONTHS
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Higher Ovulation and Pregnancy Rates in Patients With Unexplained Infertility After Application of ANTIUI Protocol: A Randomized Multicenter Controlled Study
- ClinicalTrials.gov ID
- NCT04754243
- Acronym / sponsor ID
- ANTIUI
- Conditions
- Unexplained Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Feb 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 new protocol ANTIUI provides good results regarding ovulation and pregnancy rates in patients with unexplained infertility
Detailed description
Patients with unexplained infertility has normal investigations regarding hormonal, structural data. Semen is normal but no pregnancy occurs.
Before trying ICSI, we could help these patients with ANTIUI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 parallel groups each is receiving different intervention
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: GonadotropinWill receive ANTIUI protocol |
| Control group | Active comparator | Drug: Standard protocol in IUIWill receive standard protocol in IUI and unexplained infertility |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Unexplained infertility
- Duration less than 5 years
- Good ovarian reserve AMH> 1.1
- Normal patent tubes
- No previous trials of IUI with the same protocol
Key exclusion criteria (5 listed)
- Age > 35 years
- Duration of infertility> 5 years
- Abnormal semen
- Hypoplastic tubes
- prior failed ICSI
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 |
|---|---|---|
| GonadotropinGiving patients gonadotropins and antagonist cetrotide | Drug | Study group |
| Standard protocol in IUIGiving patients gonadotropins without antagonist cetrotide | Drug | Control group |
Primary outcome
Ovulation
Time frame: 6 months
Disappearance of mature follicle
Pregnancy
Time frame: 6 months
Number of pregnant cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Yes. Within 6 MONTHS
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gonadotropin and Standard protocol in IUI in people with Unexplained Infertility, run by Tanta University 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 5 inclusion and 5 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 18 Jul 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation (time frame: 6 months). 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 18 Jul 2023.