IVF FailurePhase 4NCT03044561
Sildenafil Citrate of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development
A Phase 4 study testing Sildenafil Citrate in people with IVF Failure, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of sildenafil citrate on endometrial development in women with history of recurrent implantation failure after IVF 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
- IVF Failure
- What is being tested?
- Sildenafil Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2017to 10 Aug 2017
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- (1) cases of infertility, older than 20 years of age and not older than 40 years.
- (2) Body mass index (BMI):20-29.
- (3) women have experienced two or more implantation failure attributed to inadequate endometrial development.
Who cannot join
- (1) Uterine abnormalities (e.g. septate, bicornuate and fibroid uterus, Asherman Syndrome).
- (2) Any contraindication to sildenafil citrate or any of the components of its formulation including:
- Concurrent use of organic nitrites and nitrates.
- Severe hepatic impairment.
- Severe renal impairment.
- Hypotension.
- Recent stroke or heart attack.
Trial locations and contacts
1 site in 1 country.
ahmed khairy, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo
amr elsayed, 01090808047
About this study
Official title: Effect of Sildenafil Citrate on the Outcome of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development
The aim of this study is to evaluate the effect of sildenafil citrate on endometrial development in women with history of recurrent implantation failure after IVF
Read the detailed description
sildenafil citrate may increase endometrial thickness in women with recurrent IVF failure attributed to poor endometrial development
- Conditions
- IVF Failure
- Being tested
- Sildenafil Citrate, matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil CitrateDrug
Also called Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt
25 mg orally, 4 times per day for 21 days
matching placeboDrug
Also called placebo
orally, 4 times per day for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil citrate | Experimental | Not described Receives: Drug: Sildenafil Citrate |
| placebo | Placebo comparator | Not described Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial thickness measures
we will measure endometrial thickness by US in women with recurrent implantation failure
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start31 Jan 2017
- Primary completion1 Aug 2017 (estimated)
- Study completion10 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVF FailureStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr El-Sayed, Ain Shams University
- Investigators
- ahmed khairy, professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044561
- Sponsor's protocol ID
- amr el-sayed 2017
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sildenafil Citrate on the Outcome of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development
- ClinicalTrials.gov ID
- NCT03044561
- Acronym / sponsor ID
- amr el-sayed 2017
- Conditions
- IVF Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 1 Aug 2017 (estimated)
- Study completion
- 10 Aug 2017 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- 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 aim of this study is to evaluate the effect of sildenafil citrate on endometrial development in women with history of recurrent implantation failure after IVF
Detailed description
sildenafil citrate may increase endometrial thickness in women with recurrent IVF failure attributed to poor endometrial development
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil citrate | Experimental | Drug: Sildenafil Citrate |
| placebo | Placebo comparator | Drug: matching placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- (1) cases of infertility, older than 20 years of age and not older than 40 years.
- (2) Body mass index (BMI):20-29.
- (3) women have experienced two or more implantation failure attributed to inadequate endometrial development.
Key exclusion criteria (7 listed)
- (1) Uterine abnormalities (e.g. septate, bicornuate and fibroid uterus, Asherman Syndrome).
- (2) Any contraindication to sildenafil citrate or any of the components of its formulation including:
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 |
|---|---|---|
| Sildenafil CitrateAlso: Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt25 mg orally, 4 times per day for 21 days | Drug | Sildenafil citrate |
| matching placeboAlso: placeboorally, 4 times per day for 21 days | Drug | placebo |
Primary outcome
endometrial thickness measures
Time frame: 21 days
we will measure endometrial thickness by US in women with recurrent implantation failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: Yes
Related trials for IVF Failure
Not yet recruitingObservational study
Endometrial Immune Profile in Recurrent Implantation Failure
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Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
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Active, not recruitingObservational study
Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function?
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Enrolling by invitationObservational study
The Role of the Physiological Endometrial Microbiota in Assisted Reproduction Outcomes
Repeated IVF Failure, Microbiota
Not yet recruiting
Experimental Study on the Use of Intrauterine Infusion of Autologous Platelet-rich Plasma (PRGF-IUI) in Patients With Recurrent Implantation Failure and/or Refractory Thin Endometrium
Recurrent Implantation Failure, Endometrial Receptivity Disorders
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 khairy, professor contact
ahmed khairy, professor study director
Ain Shams University
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 Sildenafil Citrate in people with IVF Failure, run by Ain Shams 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 3 inclusion and 7 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 7 Feb 2017. 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.
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?
Contact ahmed khairy, professor (01090808047), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial thickness measures (time frame: 21 days). 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 7 Feb 2017.