InfertilityPhase 2NCT02845388
Sildenafil Citrate in Frozen Embryo Transfer
A Phase 2 study testing Sildenafil citrate and estradiol valerate in people with Infertility, run by Omar Ahmed El Sayed Saad.
Trial summary
Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Sildenafil citrate and estradiol valerate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jun 2016
- 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 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- all cases have at least 2 good quality blastocysts available for transfer
Who cannot join
- uterine structural abnormalities
- advanced uterine disease
- hydrosalpinx and pyosalpinx
About this study
Official title: Sildenafil Citrate for Endometrial Preparation in Frozen-thawed Embryo Transfer Cycles
Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.
- Conditions
- Infertility
- Being tested
- Sildenafil citrate, estradiol valerate
- Keywords
- IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil citrateDrug
Also called Viagra
estradiol valerateDrug
| Study group | Role | What they receive |
|---|---|---|
| estradiol valerate | Active comparator | estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more Receives: Drug: estradiol valerate |
| Sildenafil citrate and estradiol valerate | Active comparator | Sildenafil citrate 25 mg every 6 hours orally in combination with estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more Receives: Drug: Sildenafil citrate; Drug: estradiol valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial pattern
Endometrial pattern will be trilaminar or bilaminar after it's preparation with estradiol valerate alone or estradiol valerate and sildenafil citrate. Endometrial pattern will be estimated by transvaginal ultrasonography for trilaminar pattern every other day from 8th day till 12th day of the menstrual cycle.
Measured: starting from 8th day till 12th day of the menstrual cycle
Secondary outcomes (2)
endometrial thickness
Endometrial thickness will be estimated by transvaginal ultrasonography after it's preparation with estradiol valerate alone or estradiol valerate and sildenafil citrate for thickness 8 mm or more every other day from 8th day till 12th day of the menstrual cycle.
Measured: starting from 8th day till 12th day of menstrual cycle
biochemical pregnancy test
Serum B,human chorionic gonadotropin subunit will be measured 2 weeks after embryo transfer which will be positive when it's level exceeds 5 milli international unit /milli litre in patient's serum.
Measured: 2 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionJun 2016
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omar Ahmed El Sayed Saad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Ahmed El Sayed Saad, Ain Shams Maternity Hospital
- Investigators
- Alaa mohamed elghannam, professor, Study chair, department of obstetric and gynacology Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845388
- Sponsor's protocol ID
- Ainshams2015Omar
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 27 Jul 2016
- 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 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil Citrate for Endometrial Preparation in Frozen-thawed Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT02845388
- Acronym / sponsor ID
- Ainshams2015Omar
- Conditions
- Infertility
- Keywords
- IVF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Omar Ahmed El Sayed SaadUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jul 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.
Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| estradiol valerate | Active comparator | Drug: estradiol valerateestradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more |
| Sildenafil citrate and estradiol valerate | Active comparator | Drug: Sildenafil citrate, Drug: estradiol valerateSildenafil citrate 25 mg every 6 hours orally in combination with estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all cases have at least 2 good quality blastocysts available for transfer
Key exclusion criteria (3 listed)
- uterine structural abnormalities
- advanced uterine disease
- hydrosalpinx and pyosalpinx
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: Viagra | Drug | Sildenafil citrate and estradiol valerate |
| estradiol valerate | Drug | Sildenafil citrate and estradiol valerate, estradiol valerate |
Primary outcome
endometrial pattern
Time frame: starting from 8th day till 12th day of the menstrual cycle
Endometrial pattern will be trilaminar or bilaminar after it's preparation with estradiol valerate alone or estradiol valerate and sildenafil citrate. Endometrial pattern will be estimated by transvaginal ultrasonography for trilaminar pattern every other day from 8th day till 12th day of the menstrual cycle.
2 secondary outcomes
endometrial thickness
Time frame: starting from 8th day till 12th day of menstrual cycle
biochemical pregnancy test
Time frame: 2 weeks after embryo transfer
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 27 Jul 2016.
- 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.
Alaa mohamed elghannam, professor study chair
department of obstetric and gynacology Ain shams university
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sildenafil citrate and estradiol valerate in people with Infertility, run by Omar Ahmed El Sayed Saad.
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 1 inclusion and 3 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 27 Jul 2016. 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?
endometrial pattern (time frame: starting from 8th day till 12th day of the menstrual cycle). 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 27 Jul 2016.