IVFPhase 2/3NCT05971667
Effect of Tadalafil, Sildenafil and Pentoxyfylline on Frozen Embryo Transfer Outcomes
A Phase 2/3 study testing tadalafil, Sildenafil and pentoxifylline in people with IVF, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the Effect of different vasodilators as Tadalafil, Sildenafil and pentoxyfylline in In vitro Fertilization. In addition, the thickness of endometrium and pregnancies rates of these women will also be examined. All adverse effects of all drugs will be estimated Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- tadalafil, Sildenafil and pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2023to 30 Oct 2023
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- women having thawed embryos
Who cannot join
- hypotension
- cardiovascular, hepatic, and renal diseases;
- uncontrolled diabetes mellitus;
- ovarian cysts;
- hyperprolactinemia;
- abnormal thyroid functions;
Show all 9Show fewer
- uterine fibroids;
- patients taking nitrates;
- endometriosis and adenomyosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: "Effect of Tadalafil, Sildenafil and Pentoxyfylline on Endometrial Thickness and Frozen Embryo Transfer Outcomes
The aim of this study is to investigate the Effect of different vasodilators as Tadalafil, Sildenafil and pentoxyfylline in In vitro Fertilization. In addition, the thickness of endometrium and pregnancies rates of these women will also be examined. All adverse effects of all drugs will be estimated
Read the detailed description
A prospective randomized clinical study will be conducted in the IVF clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt. The study will These patients will be randomized into four groups.
The participants will take drugs starting from the end of menstruation cycle till endometrium reach optimal and then will start progesterone 800 mg daily.
- Conditions
- IVF
- Being tested
- tadalafil, Sildenafil, pentoxifylline
- Keywords
- Tadalafil, Sildenafil, pentoxyfylline, frozen embryo transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tadalafilDrug
Also called cialong
tadalafil 10 mg one tablet daily
SildenafilDrug
Also called Respatio
sildenafil 20 mg two tablets daily
pentoxifyllineDrug
Also called trental
pentoxifylline 400 mg two tabs daily
| Study group | Role | What they receive |
|---|---|---|
| tadalafil | Experimental | tadalafil 10 mg one tablet daily Receives: Drug: tadalafil |
| pentoxifylline | Experimental | pentoxyfilline 400 mg two tabs daily Receives: Drug: pentoxifylline |
| sildenafil | Experimental | sildenafil 20 mg two tablets Receives: Drug: Sildenafil |
| control group. | No intervention | no intervention is given |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial thickness
measured by transvaginal ultrasound
Measured: within 16 day of menstruation
Secondary outcomes (1)
pregnancy rate
number of cases positive serum pregnancy test
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971667
- Sponsor's protocol ID
- Tadalafil IVF
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- 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 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Tadalafil, Sildenafil and Pentoxyfylline on Endometrial Thickness and Frozen Embryo Transfer Outcomes
- ClinicalTrials.gov ID
- NCT05971667
- Acronym / sponsor ID
- Tadalafil IVF
- Conditions
- IVF
- Keywords
- Tadalafil, Sildenafil, pentoxyfylline, frozen embryo transfer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 2 Aug 2023 (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 aim of this study is to investigate the Effect of different vasodilators as Tadalafil, Sildenafil and pentoxyfylline in In vitro Fertilization. In addition, the thickness of endometrium and pregnancies rates of these women will also be examined. All adverse effects of all drugs will be estimated
Detailed description
A prospective randomized clinical study will be conducted in the IVF clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt. The study will These patients will be randomized into four groups.
The participants will take drugs starting from the end of menstruation cycle till endometrium reach optimal and then will start progesterone 800 mg daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tadalafil | Experimental | Drug: tadalafiltadalafil 10 mg one tablet daily |
| pentoxifylline | Experimental | Drug: pentoxifyllinepentoxyfilline 400 mg two tabs daily |
| sildenafil | Experimental | Drug: Sildenafilsildenafil 20 mg two tablets |
| control group. | No intervention | –no intervention is given |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women having thawed embryos
Key exclusion criteria (9 listed)
- hypotension
- cardiovascular, hepatic, and renal diseases;
- uncontrolled diabetes mellitus;
- ovarian cysts;
- hyperprolactinemia;
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 |
|---|---|---|
| tadalafilAlso: cialongtadalafil 10 mg one tablet daily | Drug | tadalafil |
| SildenafilAlso: Respatiosildenafil 20 mg two tablets daily | Drug | sildenafil |
| pentoxifyllineAlso: trentalpentoxifylline 400 mg two tabs daily | Drug | pentoxifylline |
Primary outcome
endometrial thickness
Time frame: within 16 day of menstruation
measured by transvaginal ultrasound
1 secondary outcome
pregnancy rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tadalafil, Sildenafil and pentoxifylline in people with IVF, run by Beni-Suef 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 1 inclusion and 9 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 Aug 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
endometrial thickness (time frame: within 16 day of menstruation). 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 Aug 2023.