InfertilityPhase 4NCT02890238
Sildenafil Effect After Ovulation Induction
A Phase 4 study testing Clomiphene citrate and sildenafil citrate in people with Infertility, run by Cairo University at 1 site in Egypt.
Trial summary
100 women with infertility classified into 2 groups. Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Clomiphene citrate and sildenafil citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2016to Dec 2019
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women whether it's primary or secondary infertility
- Woman's age: (18-35 years old)
- Menstrual cycle from (24-35 days)
- Normal semen analysis
Who cannot join
- Age more than 35 years old
- Ovarian cysts
- Abnormal hormonal profile (e.g hyperprolactinaemia)
- Significant cardiovascular disease
- Serious liver disease or renal failure
- Poorly controlled diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Official title: Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation
100 women with infertility classified into 2 groups.
Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.
Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.
Read the detailed description
100 women with infertility classified into 2 groups.
Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.
Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.
Folliculometry was assessed by:
- Transvaginal ultrasound: It was done on day 11th of the cycle to detect number of follicles and endometrial thickness.
When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation to both groups.
Pregnancy was assessed by:
- Beta HCG test: (Radioimmunoassay)
- Conditions
- Infertility
- Being tested
- Clomiphene citrate, sildenafil citrate, Placebo
- Keywords
- Sildenafil Citrate, Induction of Ovulation, Pregnancy Rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene citrateDrug
Also called clomid
50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle
sildenafil citrateDrug
Also called Viagra
20mg tab from 7th-11th day of the same cycle orally 3times/day
PlaceboDrug
tab from 7th-11th day of the same cycle orally 3times/day
| Study group | Role | What they receive |
|---|---|---|
| sildenafil citrate | Active comparator | 50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd - 7th day of the cycle and sildenafil citrate 20mg tab from 7th-11th day of the same cycle orally 3times/day Receives: Drug: Clomiphene citrate; Drug: sildenafil citrate |
| placebo group | Placebo comparator | 50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd- 7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day Receives: Drug: Clomiphene citrate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate per cycle
Serum pregnancy test
Measured: 14 days after HCG triggering of ovulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890238
- Sponsor's protocol ID
- 156
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2016
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation
- ClinicalTrials.gov ID
- NCT02890238
- Acronym / sponsor ID
- 156
- Conditions
- Infertility
- Keywords
- Sildenafil Citrate, Induction of Ovulation, Pregnancy Rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Sep 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.
100 women with infertility classified into 2 groups.
Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.
Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.
Detailed description
100 women with infertility classified into 2 groups.
Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.
Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.
Folliculometry was assessed by:
- Transvaginal ultrasound: It was done on day 11th of the cycle to detect number of follicles and endometrial thickness.
When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation to both groups.
Pregnancy was assessed by:
- Beta HCG test: (Radioimmunoassay)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sildenafil citrate | Active comparator | Drug: Clomiphene citrate, Drug: sildenafil citrate50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd - 7th day of the cycle and sildenafil citrate 20mg tab from 7th-11th day of the same cycle orally 3times/day |
| placebo group | Placebo comparator | Drug: Clomiphene citrate, Drug: Placebo50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd- 7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile women whether it's primary or secondary infertility
- Woman's age: (18-35 years old)
- Menstrual cycle from (24-35 days)
- Normal semen analysis
Key exclusion criteria (6 listed)
- Age more than 35 years old
- Ovarian cysts
- Abnormal hormonal profile (e.g hyperprolactinaemia)
- Significant cardiovascular disease
- Serious liver disease or renal failure
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 |
|---|---|---|
| Clomiphene citrateAlso: clomid50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle | Drug | placebo group, sildenafil citrate |
| sildenafil citrateAlso: Viagra20mg tab from 7th-11th day of the same cycle orally 3times/day | Drug | sildenafil citrate |
| Placebotab from 7th-11th day of the same cycle orally 3times/day | Drug | placebo group |
Primary outcome
Pregnancy rate per cycle
Time frame: 14 days after HCG triggering of ovulation
Serum pregnancy test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: Yes
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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.
Ahmed Maged principal investigator
Kasr Alainy medical school
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 Clomiphene citrate and sildenafil citrate in people with Infertility, run by Cairo 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 4 inclusion and 6 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 23 Sep 2019. 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 Maged (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate per cycle (time frame: 14 days after HCG triggering of ovulation). 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 23 Sep 2019.