Recurrent Implantation FailurePhase 2NCT03498703
Azathioprine in Recurrent Implantation Failure
A Phase 2 study testing Azathioprine Pill in people with Recurrent Implantation Failure and In Vitro Fertilization, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Azathioprine increase pregnancy rate in patients with recurrent implantation failure Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Implantation Failure, In Vitro Fertilization, Intracytoplsmic Sperm Injection
- What is being tested?
- Azathioprine Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Apr 2018to 1 Jul 2019
- Phase
- Phase 2
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 20-39
- previous 3 or more failed ivf
Who cannot join
- intrauterine anomalies
- chronic systemic illness
- chronic pelvic conditions
- sensitivety to azathioprine
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain Shams University, Maternity Hospital
Cairo
Capital Birth Center
Cairo
About this study
Azathioprine increase pregnancy rate in patients with recurrent implantation failure
- Being tested
- Azathioprine Pill, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azathioprine PillDrug
Azathioprine increase pregnancy rate in cases with recurrent implantaion failure
Placebo Oral TabletDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Azathioprine | Experimental | Not described Receives: Drug: Azathioprine Pill |
| Control | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 2 weeks
Secondary outcomes (1)
Side effects
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start25 Apr 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Implantation FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Birth Center
- Responsible party
- Principal investigator, Ahmed Reda, Ain Shams University
- Investigators
- Ahmed H Salama, Study director, Capital Birth Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498703
- Sponsor's protocol ID
- FW000372
- Status last verified
- Jul 2019
- First submitted
- 7 Apr 2018
- Last updated
- 24 Jul 2019
- 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 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azathioprine in Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT03498703
- Acronym / sponsor ID
- FW000372
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Capital Birth Center
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 17 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.
Azathioprine increase pregnancy rate in patients with recurrent implantation failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azathioprine | Experimental | Drug: Azathioprine Pill |
| Control | Placebo comparator | Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age: 20-39
- previous 3 or more failed ivf
Key exclusion criteria (4 listed)
- intrauterine anomalies
- chronic systemic illness
- chronic pelvic conditions
- sensitivety to azathioprine
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 |
|---|---|---|
| Azathioprine PillAzathioprine increase pregnancy rate in cases with recurrent implantaion failure | Drug | Azathioprine |
| Placebo Oral TabletPlacebo tablets | Drug | Control |
Primary outcome
Clinical pregnancy rate
Time frame: 2 weeks
1 secondary outcome
Side effects
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Implantation Failure
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.
Ahmed H Salama study director
Capital Birth Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azathioprine Pill in people with Recurrent Implantation Failure and In Vitro Fertilization, run by Ain Shams University at 2 sites 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 2 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 24 Jul 2019.