Subfertility, FemalePhase 4NCT05753098
Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility
A Phase 4 study testing estrogen therapy, Sildenafil and Clomiphene Citrate 50mg in people with Subfertility, Female, run by Beni-Suef University at 1 site in Egypt.
Trial summary
. This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women. 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
- Subfertility, Female
- What is being tested?
- estrogen therapy, Sildenafil 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
- 148 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2021to 31 Jan 2023
- 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
- aged between 18 to 40 years
- unexplained infertility (primary or secondary)
- had a regular menstrual cycle;
- patent tubes;
- husbands with normal semen parameters.
Who cannot join
- hypotension;
- cardiovascular, hepatic, and renal diseases;
- uncontrolled diabetes mellitus;
- anovulatory infertility;
- ovarian cysts;
- pelvic adhesions;
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- hyperprolactinemia;
- abnormal thyroid functions;
- multiple uterine fibroids;
- patients on nitrates;
- suspicion of endometriosis and adenomyosis,
- subjects have known to receive any treatment for fertility in the last six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy on Improvement of Endometrial Thickness and Treatment of Unexplained Infertility
. This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.
Read the detailed description
The study is a randomized controlled trial that was carried on 148 infertile women with unexplained infertility. Patients were divided into 3 groups. Group 1 included 48 patients who received oral estradiol valerate (Cyclo-Progynova 2mg, from day 8th till triggering of ovulation), another 50 patients in group 2 received oral Sildenafil (Respatio 20mg/12hr film coated tablets for 5 days starting from last day of menstruation till ovulation), while group 3 was the control one who included 50 patients were given ovulation induction with CC 50mg/12hr from 2nd to 7th day of cycle. Every patient underwent a transvaginal ultrasound to determine ovulation, number of follicles, and pregnancy rates. Miscarriage, ectopic pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse consequences.
- Conditions
- Subfertility, Female
- Being tested
- estrogen therapy, Sildenafil, 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.
estrogen therapyDrug
Also called white tablet of cycloprogynova
oral estradiol valerate
SildenafilDrug
Also called Respatio
PDE5 inhibitor
Clomiphene Citrate 50mgDrug
Also called Technovula
used for ovulation induction
| Study group | Role | What they receive |
|---|---|---|
| estrogen therapy in addition to clomiphene citrate | Experimental | received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle and estrogen (Cyclopregnova® 2mg, white tablets, BAYER Schering pharma), one tablet every 12 hour from day 8th till triggering of ovulation. Receives: Drug: estrogen therapy; Drug: Clomiphene Citrate 50mg |
| sildenafil in addition to clomiphene citrate | Experimental | received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as and Sildenafil (Respatio® 20mg film coated tablets for 5 days) from last day of menstruation till reaching optimal size of follicle and endometrial thickness Receives: Drug: Sildenafil; Drug: Clomiphene Citrate 50mg |
| clomiphene citrate alone | Other | received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as in the first and second groups in addition to 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 rates
measure B HCG and detect number of cases get pregnant in each cycle 28 days
Measured: at the end of each of 3 cycles (28 days)
Secondary outcomes (1)
ovulation
measuring dominant follicle starting from D9 of the cycle till reaching 18-20mm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start15 Jan 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subfertility, 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 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, Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753098
- Sponsor's protocol ID
- REC-H-PhBSU-22022
- Status last verified
- Apr 2023
- First submitted
- 21 Feb 2023
- Last updated
- 28 Apr 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy on Improvement of Endometrial Thickness and Treatment of Unexplained Infertility
- ClinicalTrials.gov ID
- NCT05753098
- Acronym / sponsor ID
- REC-H-PhBSU-22022
- Conditions
- Subfertility, Female
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 3 Mar 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.
. This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.
Detailed description
The study is a randomized controlled trial that was carried on 148 infertile women with unexplained infertility. Patients were divided into 3 groups. Group 1 included 48 patients who received oral estradiol valerate (Cyclo-Progynova 2mg, from day 8th till triggering of ovulation), another 50 patients in group 2 received oral Sildenafil (Respatio 20mg/12hr film coated tablets for 5 days starting from last day of menstruation till ovulation), while group 3 was the control one who included 50 patients were given ovulation induction with CC 50mg/12hr from 2nd to 7th day of cycle. Every patient underwent a transvaginal ultrasound to determine ovulation, number of follicles, and pregnancy rates. Miscarriage, ectopic pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse consequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| estrogen therapy in addition to clomiphene citrate | Experimental | Drug: estrogen therapy, Drug: Clomiphene Citrate 50mgreceived clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle and estrogen (Cyclopregnova® 2mg, white tablets, BAYER Schering pharma), one tablet every 12 hour from day 8th till triggering of ovulation. |
| sildenafil in addition to clomiphene citrate | Experimental | Drug: Sildenafil, Drug: Clomiphene Citrate 50mgreceived clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as and Sildenafil (Respatio® 20mg film coated tablets for 5 days) from last day of menstruation till reaching optimal size of follicle and endometrial thickness |
| clomiphene citrate alone | Other | Drug: Clomiphene Citrate 50mgreceived clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as in the first and second groups in addition to placebo tablet. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged between 18 to 40 years
- unexplained infertility (primary or secondary)
- had a regular menstrual cycle;
- patent tubes;
- husbands with normal semen parameters.
Key exclusion criteria (12 listed)
- hypotension;
- cardiovascular, hepatic, and renal diseases;
- uncontrolled diabetes mellitus;
- anovulatory infertility;
- ovarian cysts;
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 |
|---|---|---|
| estrogen therapyAlso: white tablet of cycloprogynovaoral estradiol valerate | Drug | estrogen therapy in addition to clomiphene citrate |
| SildenafilAlso: RespatioPDE5 inhibitor | Drug | sildenafil in addition to clomiphene citrate |
| Clomiphene Citrate 50mgAlso: Technovulaused for ovulation induction | Drug | clomiphene citrate alone, estrogen therapy in addition to clomiphene citrate, sildenafil in addition to clomiphene citrate |
Primary outcome
pregnancy rates
Time frame: at the end of each of 3 cycles (28 days)
measure B HCG and detect number of cases get pregnant in each cycle 28 days
1 secondary outcome
ovulation
Time frame: 3 months
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 28 Apr 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
Clinical Pharmacy Faculty of Pharmacy 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 4 study testing estrogen therapy, Sildenafil and Clomiphene Citrate 50mg in people with Subfertility, 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 28 Apr 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?
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 rates (time frame: at the end of each of 3 cycles (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 28 Apr 2023.