Recurrent Pregnancy LossPhase 2NCT04718233
Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss
A Phase 2 study testing Sildenafil 25Mg Tablet in people with Recurrent Pregnancy Loss, run by Ain Shams University at 1 site in Egypt.
Trial summary
Patients with recurrent pregnancy loss are known to have decreased uterine artery blood flow. Nitric oxide plays a major role in increasing uterine blood flow during the luteal phase. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Pregnancy Loss
- What is being tested?
- Sildenafil 25Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2018to 1 Jul 2019
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- History of 2 or more unexplained recurrent miscarriage.
- Child bearing period (18-35 years old).
- Non pregnant state.
- Regular menstrual cycles for the previous three months before the study.
- No hormonal contraception or intrauterine device.
- impaired uterine artery blood flow (PI >2.02) (Mansour et al., 2018).
Who cannot join
- 1-Having any possible causes of abortion: anatomical, genetic, endocrinological, infectious, or immunological.
- 2- Autoimmune disorders which may affect blood vessels and their blood flow (systemic lupus).
- 3- Systemic disease that might affect the hemodynamic indices (e.g. thrombocytopenia, thyrotoxicosis … etc.).
- 4- Diagnosed or treated thrombophilia. 5- Any vascular disease (e.g. coronary artery disease). 6- History of oophorectomy. 7- History of consanguinity. 8- Family history of chromosomal abnormalities (e.g. trisomy 21, trisomy 13… etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss Due to Impaired Uterine Artery Blood Flow
Patients with recurrent pregnancy loss are known to have decreased uterine artery blood flow. Nitric oxide plays a major role in increasing uterine blood flow during the luteal phase. This study is done to evaluate the effects of sildenafil on blood flow indices in the patients with recurrent pregnancy loss due to impaired uterine artery blood flow.
Read the detailed description
Study Setting: The study will be conducted in recurrent pregnancy loss outpatient clinic at Ain shams university maternity hospital.
Study Population: Patients with unexplained recurrent miscarriage attending Ain shams university maternity hospital's outpatient clinic. This study will be conducted on 80 women distributed into 2 groups each is 40 women in fertile age with history of two or more recurrent spontaneous abortions and decreased uterine artery blood flow(PI>2.02(Mansour et al., 2018). First group will be placebo controlled and the second group will be given sildenafil citrate.
Women will be asked to attend during the 21-23 day of the cycle and will be subjected to: History taking and Full clinical examination.
Clinical examination will be done including general, abdominal and pelvic examination.
General examination: including general appearance, weight, height and vital signs Abdominal examination: to assure freedom of any organic clinically detectable pathologic lesions.
Pelvic examination: included inspection of the external genitalia, speculum examination of the vagina to rule out infection, and bimanual assessment of uterine size and position as well as exclusion of adnexal masses.
Laboratory investigations:
Routine investigations including: CBC, fasting and postprandial blood sugar, urine analysis, kidney function and liver function will be done.
The endocrine evaluation consisted in measuring thyroid-stimulating hormone, free thyroxin, and progesterone levels on day 21 of the menstrual cycle.
Sonography:
Sonography will be performed using Samsung H60 with convex probe (multi-frequency AD 2~ 8 MHz) to perform trans-vaginal examination. Examination will be performed in the second phase of the menstrual cycle, at mid-luteal day.
Pulsed wave Doppler will be used to obtain clear, consistent, flow velocity wave forms of both uterine arteries. Pulsatility index (PI) will be measured bilaterally. The PI reported will be the arithmetic mean for the last three cardiac cycles.
(Goswamy and Steptoe, 1988) classification will be used to determine the wave types. According to this classification, the FVW of the circumflex artery can be of 3 types : Type A when the diastolic component is present but not continuous with the systole, and ends before the next cardiac cycle.
Type B when a diastole is present and continues with the systole, but ends before the next cardiac cycle.
Type C when a diastole is present and continues with the systole and into the next cardiac cycle.
The majority of research has centered on an elevation in the RI or PI to detect the presence of increased uterine artery blood flow resistance in non- pregnant states. Criteria for an abnormal uterine artery Pulsatility index (PI) cutoff (PI> 2.02) and abnormal sub-endometrial blood flow Resistant Index (RI) (RI>0.6) (Mansour et al., 2018).
Steps and methods:
The participants will be two groups of 80 patients with history of recurrent pregnancy loss, each is 40.
All patients will be scanned transvaginally with transvaginal Doppler sonography 6 to 8 days after ovulation to measure the pulsatility index (PI), resistance index (RI) and systolic to diastolic ratio (S/D) of the right and left main uterine arteries and sub-endometrial blood flow resistance index (RI). Sildenafil citrate at a dose of 25mg or placebo will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured after 3 hours. The student test will be used for analysis of the results, P< 0.05 will be considered significant.
With 95% confidence interval. P values ≥5% considered to be significant.
- Conditions
- Recurrent Pregnancy Loss
- Being tested
- Sildenafil 25Mg Tablet, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 25Mg TabletDrug
Sildenafil citrate at a dose of 25mg will be administered orally in patients with recurrent pregnancy loss
Placebo Oral TabletDrug
placebo will be administered orally in patients with recurrent pregnancy loss
| Study group | Role | What they receive |
|---|---|---|
| sildenafil citrate | Experimental | Sildenafil citrate at a dose of 25mg will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours. Receives: Drug: Sildenafil 25Mg Tablet |
| placebo | Placebo comparator | placebo will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
uterine artery blood flow indices
uterine artery PI, RI
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start5 Sep 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abass, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718233
- Sponsor's protocol ID
- sildenafilcitrate89
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss Due to Impaired Uterine Artery Blood Flow
- ClinicalTrials.gov ID
- NCT04718233
- Acronym / sponsor ID
- sildenafilcitrate89
- Conditions
- Recurrent Pregnancy Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 22 Jan 2021 (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.
Patients with recurrent pregnancy loss are known to have decreased uterine artery blood flow. Nitric oxide plays a major role in increasing uterine blood flow during the luteal phase. This study is done to evaluate the effects of sildenafil on blood flow indices in the patients with recurrent pregnancy loss due to impaired uterine artery blood flow.
Detailed description
Study Setting: The study will be conducted in recurrent pregnancy loss outpatient clinic at Ain shams university maternity hospital.
Study Population: Patients with unexplained recurrent miscarriage attending Ain shams university maternity hospital's outpatient clinic. This study will be conducted on 80 women distributed into 2 groups each is 40 women in fertile age with history of two or more recurrent spontaneous abortions and decreased uterine artery blood flow(PI>2.02(Mansour et al., 2018). First group will be placebo controlled and the second group will be given sildenafil citrate.
Women will be asked to attend during the 21-23 day of the cycle and will be subjected to: History taking and Full clinical examination.
Clinical examination will be done including general, abdominal and pelvic examination.
General examination: including general appearance, weight, height and vital signs Abdominal examination: to assure freedom of any organic clinically detectable pathologic lesions.
Pelvic examination: included inspection of the external genitalia, speculum examination of the vagina to rule out infection, and bimanual assessment of uterine size and position as well as exclusion of adnexal masses.
Laboratory investigations:
Routine investigations including: CBC, fasting and postprandial blood sugar, urine analysis, kidney function and liver function will be done.
The endocrine evaluation consisted in measuring thyroid-stimulating hormone, free thyroxin, and progesterone levels on day 21 of the menstrual cycle.
Sonography:
Sonography will be performed using Samsung H60 with convex probe (multi-frequency AD 2~ 8 MHz) to perform trans-vaginal examination. Examination will be performed in the second phase of the menstrual cycle, at mid-luteal day.
Pulsed wave Doppler will be used to obtain clear, consistent, flow velocity wave forms of both uterine arteries. Pulsatility index (PI) will be measured bilaterally. The PI reported will be the arithmetic mean for the last three cardiac cycles.
(Goswamy and Steptoe, 1988) classification will be used to determine the wave types. According to this classification, the FVW of the circumflex artery can be of 3 types : Type A when the diastolic component is present but not continuous with the systole, and ends before the next cardiac cycle.
Type B when a diastole is present and continues with the systole, but ends before the next cardiac cycle.
Type C when a diastole is present and continues with the systole and into the next cardiac cycle.
The majority of research has centered on an elevation in the RI or PI to detect the presence of increased uterine artery blood flow resistance in non- pregnant states. Criteria for an abnormal uterine artery Pulsatility index (PI) cutoff (PI> 2.02) and abnormal sub-endometrial blood flow Resistant Index (RI) (RI>0.6) (Mansour et al., 2018).
Steps and methods:
The participants will be two groups of 80 patients with history of recurrent pregnancy loss, each is 40.
All patients will be scanned transvaginally with transvaginal Doppler sonography 6 to 8 days after ovulation to measure the pulsatility index (PI), resistance index (RI) and systolic to diastolic ratio (S/D) of the right and left main uterine arteries and sub-endometrial blood flow resistance index (RI). Sildenafil citrate at a dose of 25mg or placebo will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured after 3 hours. The student test will be used for analysis of the results, P< 0.05 will be considered significant.
With 95% confidence interval. P values ≥5% considered to be significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sildenafil citrate | Experimental | Drug: Sildenafil 25Mg TabletSildenafil citrate at a dose of 25mg will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours. |
| placebo | Placebo comparator | Drug: Placebo Oral Tabletplacebo will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- History of 2 or more unexplained recurrent miscarriage.
- Child bearing period (18-35 years old).
- Non pregnant state.
- Regular menstrual cycles for the previous three months before the study.
- No hormonal contraception or intrauterine device.
Key exclusion criteria (4 listed)
- 1-Having any possible causes of abortion: anatomical, genetic, endocrinological, infectious, or immunological.
- 2- Autoimmune disorders which may affect blood vessels and their blood flow (systemic lupus).
- 3- Systemic disease that might affect the hemodynamic indices (e.g. thrombocytopenia, thyrotoxicosis … etc.).
- 4- Diagnosed or treated thrombophilia. 5- Any vascular disease (e.g. coronary artery disease). 6- History of oophorectomy. 7- History of consanguinity. 8- Family history of chromosomal abnormalities (e.g. trisomy 21, trisomy 13… etc.).
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 25Mg TabletSildenafil citrate at a dose of 25mg will be administered orally in patients with recurrent pregnancy loss | Drug | sildenafil citrate |
| Placebo Oral Tabletplacebo will be administered orally in patients with recurrent pregnancy loss | Drug | placebo |
Primary outcome
uterine artery blood flow indices
Time frame: 3 hours
uterine artery PI, RI
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 22 Jan 2021.
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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 study testing Sildenafil 25Mg Tablet in people with Recurrent Pregnancy Loss, run by Ain Shams 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 6 inclusion and 4 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 22 Jan 2021. 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 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?
uterine artery blood flow indices (time frame: 3 hours). 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 22 Jan 2021.