AnovulatoryPhase 2NCT02663830
The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene
A Phase 2 study testing Sildenafil & clomiphene citrate and clomiphene only in people with Anovulatory, run by Ain Shams University.
Trial summary
The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women only
- Conditions the study is for
- Anovulatory
- What is being tested?
- Sildenafil & clomiphene citrate and clomiphene only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2016to 12 Mar 2017
- 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 21 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women age 21-35 years.
- Anovulatory cycles due to polycystic ovaries syndrome.
- Non-smokers.
- Free of major medical illness
Who cannot join
- Women with myoma or adenomyosis
- Women with congenital uterine anomaly.
- Chronic use of any medications including non-steroidal anti-inflammatory drugs.
- Associated cases of infertility other than PCOs (male factor, tubal factor,….).
- Asherman syndrome.
- Cases with endometrial hyperplasia.
- Cases with endometrial polyp
About this study
Official title: The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene: A Randomized Controlled Trial.
The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate.
- Conditions
- Anovulatory
- Being tested
- Sildenafil & clomiphene citrate, clomiphene only
- Medical subject headings
- Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil & clomiphene citrateDrug
Also called seldin and clomid
105 Patients will receive 25 mg sildenafil citrate 6hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation
clomiphene onlyDrug
Also called clomid
105 Patients will receive clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation
| Study group | Role | What they receive |
|---|---|---|
| (Sildenafil & clomiphene citrate group) | Experimental | 105 Patients will receive 25 mg sildenafil citrate 6 hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation Receives: Drug: Sildenafil & clomiphene citrate |
| clomiphene only | Active comparator | 105 patients will receive only clomiphene citrate 100mg/day (day 2 to 6) orally (2 tablets at same time daily). Receives: Drug: clomiphene only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 6 weeks
Secondary outcomes (4)
endometrial thickness
Measured: 2 weeks
miscarriage rate
Measured: 13 weeks
ectopic pregnancy rate
Measured: 8 weeks
Side Effects of Vasodilators
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start10 Jan 2016
- Primary completion10 Jan 2017
- Study completion12 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnovulatoryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Shafy El Shahawy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663830
- Sponsor's protocol ID
- SIOO
- Status last verified
- Aug 2017
- First submitted
- 21 Jan 2016
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02663830
- Acronym / sponsor ID
- SIOO
- Conditions
- Anovulatory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 12 Mar 2017 (actual)
- First posted
- 26 Jan 2016 (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 the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Sildenafil & clomiphene citrate group) | Experimental | Drug: Sildenafil & clomiphene citrate105 Patients will receive 25 mg sildenafil citrate 6 hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation |
| clomiphene only | Active comparator | Drug: clomiphene only105 patients will receive only clomiphene citrate 100mg/day (day 2 to 6) orally (2 tablets at same time daily). |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women age 21-35 years.
- Anovulatory cycles due to polycystic ovaries syndrome.
- Non-smokers.
- Free of major medical illness
Key exclusion criteria (7 listed)
- Women with myoma or adenomyosis
- Women with congenital uterine anomaly.
- Chronic use of any medications including non-steroidal anti-inflammatory drugs.
- Associated cases of infertility other than PCOs (male factor, tubal factor,….).
- Asherman syndrome.
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 & clomiphene citrateAlso: seldin and clomid105 Patients will receive 25 mg sildenafil citrate 6hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation | Drug | (Sildenafil & clomiphene citrate group) |
| clomiphene onlyAlso: clomid105 Patients will receive clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation | Drug | clomiphene only |
Primary outcome
Clinical pregnancy rate
Time frame: 6 weeks
4 secondary outcomes
endometrial thickness
Time frame: 2 weeks
miscarriage rate
Time frame: 13 weeks
ectopic pregnancy rate
Time frame: 8 weeks
Side Effects of Vasodilators
Time frame: 4 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 16 Aug 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sildenafil & clomiphene citrate and clomiphene only in people with Anovulatory, run by Ain Shams University.
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 4 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: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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: 6 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 16 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.