Infertility, FemalePhase 2/3NCT05846906
Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness
A Phase 2/3 study testing Sildenafil Citrate and Clomiphene Citrate 50mg in people with Infertility, Female, run by Beni-Suef University at 1 site in Egypt.
Trial summary
One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Sildenafil Citrate and Clomiphene Citrate 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 30 Apr 2022
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages of 18 to 40
- patent tubes
- unexplained infertility
- regular menstrual cycle
- husband with normal sperm parameters
Who cannot join
- hypotension
- cardiovascular, renal and hepatic diseases
- uncontrolled diabetes mellitus
- anovulatory infertility
- abnormal thyroid functions
- ovarian cysts
Show all 12Show fewer
- patients taking nitrates
- pelvic adhesions
- abnormal hormonal profile.
- hyperprolactinemia
- multiple uterine fibroids
- adenomyosis and endometriosis suspicion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women
One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation.
Read the detailed description
One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end of menstruation through ovulation. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic pregnancy, and multiple pregnancies, were monitored.
- Conditions
- Infertility, Female
- Being tested
- Sildenafil Citrate, Clomiphene Citrate 50mg
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil CitrateDrug
Also called respatio
oral sildenafil (Respatio® 20mg )
Clomiphene Citrate 50mgDrug
Also called technovula
used for ovionulation induct
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil and clomiphene citrate | Experimental | Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the experimental group from day 2 through day 7 of the cycle, and oral sildenafil (Respatio® 20mg for 5 days) was taken from the last day of menstruation until reaching ovulation. Receives: Drug: Sildenafil Citrate; Drug: Clomiphene Citrate 50mg |
| clomiphene citrate alone | Other | Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the control group from day 2 through day 7 of the cycle in addition to a placebo tablet. Receives: Drug: Clomiphene Citrate 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Serum pregnancy test (positive/negative)
Measured: at the end of the cycle (28 days)
Secondary outcomes (2)
endometrial thickness
measured by trans-vaginal ultrasound
Measured: 1 month
ovulation rate
using trans-vaginal ultrasound
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 posted6 May 2023
- Study start1 Oct 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (actual)
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
- Investigators
- Beni-Suef University, Study director, Faculty of Medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846906
- Sponsor's protocol ID
- REC-H-PhBSU-21015
- Status last verified
- May 2023
- First submitted
- 15 Apr 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women
- ClinicalTrials.gov ID
- NCT05846906
- Acronym / sponsor ID
- REC-H-PhBSU-21015
- Conditions
- Infertility, Female
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 6 May 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.
One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation.
Detailed description
One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end of menstruation through ovulation. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic pregnancy, and multiple pregnancies, were monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil and clomiphene citrate | Experimental | Drug: Sildenafil Citrate, Drug: Clomiphene Citrate 50mgOral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the experimental group from day 2 through day 7 of the cycle, and oral sildenafil (Respatio® 20mg for 5 days) was taken from the last day of menstruation until reaching ovulation. |
| clomiphene citrate alone | Other | Drug: Clomiphene Citrate 50mgOral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the control group from day 2 through day 7 of the cycle in addition to a placebo tablet. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ages of 18 to 40
- patent tubes
- unexplained infertility
- regular menstrual cycle
- husband with normal sperm parameters
Key exclusion criteria (12 listed)
- hypotension
- cardiovascular, renal and hepatic diseases
- uncontrolled diabetes mellitus
- anovulatory infertility
- abnormal thyroid functions
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: respatiooral sildenafil (Respatio® 20mg ) | Drug | Sildenafil and clomiphene citrate |
| Clomiphene Citrate 50mgAlso: technovulaused for ovionulation induct | Drug | Sildenafil and clomiphene citrate, clomiphene citrate alone |
Primary outcome
Pregnancy rate
Time frame: at the end of the cycle (28 days)
Serum pregnancy test (positive/negative)
2 secondary outcomes
endometrial thickness
Time frame: 1 month
ovulation rate
Time frame: 1 month
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 30 May 2023.
- Individual participant dataSharing planned: No
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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.
Beni-Suef University study director
Faculty of Medicine Beni-Suef University
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 Sildenafil Citrate and Clomiphene Citrate 50mg in people with Infertility, Female, 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 5 inclusion and 12 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 30 May 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?
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?
Pregnancy rate (time frame: at the end of the cycle (28 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 30 May 2023.