Endometrial PreparationPhase 4sildenafilNCT01668446
Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles
A Phase 4 study testing Sildenafil and estradiol valerat in people with Endometrial Preparation and Frozen Embryo Transfer, run by farzaneh hojjat at 1 site in Iran.
Trial summary
The target of this study was an estimate the result of sildenafil on ultrasonographic endometrial thickness, endometrial pattern investigation estrogen level on the day of progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles . Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Preparation, Frozen Embryo Transfer
- What is being tested?
- Sildenafil and estradiol valerat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIran
- Study dates
- Sep 2009to Feb 2011
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women > 40 years old,
- history of endocrine disease
- Hysteroscopic surgery
- cardiovascular, renal and liver disease
- hypotension( blood pressure < 90/50)
- history of stroke or myocardial infarction
- use of alcohol or substance
Who cannot join
- A total of 80 patients with antecedent of poor endometrial response and had frozen embryo included in this study all women must to be < 40 years old,
- no history of endocrine disease,
- no Hysteroscopic surgery, had a high quality embryos no cardiovascular,
- renal and liver disease and
- no hypotension (blood pressure < 90/50) or
- history of stroke or myocardial infarction and
- don't use of alcohol or substance Patients with these conditions enter this study and based on randomized tables are divided in two groups.
Trial locations and contacts
1 site in 1 country.
About this study
The target of this study was an estimate the result of sildenafil on ultrasonographic endometrial thickness, endometrial pattern investigation estrogen level on the day of progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .
- Conditions
- Endometrial Preparation, Frozen Embryo Transfer
- Being tested
- Sildenafil, estradiol valerat
- Keywords
- Sildenafil, Endometrial thickness, Frozen embryo transfer, ultrasonographic endometrial thickness, endometrial pattern, Implantation rate, chemical pregnancy rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
sildenafil tablets(50 mg) daily
estradiol valeratDrug
| Study group | Role | What they receive |
|---|---|---|
| sildenafil | Experimental | One of two group to prepare the endometrium give estradiol by step up method with menstruation.
From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily. Receives: Drug: Sildenafil |
| Sildenafil and estradiol valerat | Experimental | One of two group to prepare the endometrium give estradiol by step up method with menstruation.
From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily. Receives: Drug: Sildenafil; Drug: estradiol valerat |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate the result of sildenafil on ultrasonographic endometrial thickness
Assays:
Day 13 of menstrual cycle endometrial thickness estimated with Transvaginal ultrasonographic(arranged in a series every other day), evaluations were performed by a single investigator, If the endometrial thickness is more than 8mm progesterone injected 100 mg intramuscular and Estrogen, progesterone and lh measured in blood sample then after three days embryo transferred.
Measured: between 2009-2011 (up to 2 years)
Secondary outcomes (1)
estimate the result of sildenafil on Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .
Implantation rate was higher in sildenafil Group but not significant chemical pregnancy rates were higher in sildenafil Group but not significant.
Measured: between 2009-2011 (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startSep 2009
- Primary completionSep 2009
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial PreparationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- farzaneh hojjat
- Sponsor type
- University, hospital or other
- Collaborators
- Razieh dehghani firouzabadi, Robab davar
- Responsible party
- Sponsor-investigator, farzaneh hojjat, Shahid Sadoughi University of Medical Sciences and Health Services
- Investigators
- farzaneh hojjat, MD, Principal investigator, Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science, Bouali Ave. Safaieh, Yazd,Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668446
- Sponsor's protocol ID
- radvin123
- Other IDs
- rad123, rad123
- Acronym
- sildenafil
- Status last verified
- Sep 2012
- First submitted
- 24 Jun 2012
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT01668446
- Acronym / sponsor ID
- sildenafil / radvin123
- Conditions
- Endometrial Preparation, Frozen Embryo Transfer
- Keywords
- Sildenafil, Endometrial thickness, Frozen embryo transfer, ultrasonographic endometrial thickness, endometrial pattern, Implantation rate, chemical pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- farzaneh hojjatUniversity, hospital or other
- Collaborators
- Razieh dehghani firouzabadi, Robab davar
- Study start
- Sep 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 Aug 2012 (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 target of this study was an estimate the result of sildenafil on ultrasonographic endometrial thickness, endometrial pattern investigation estrogen level on the day of progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sildenafil | Experimental | Drug: SildenafilOne of two group to prepare the endometrium give estradiol by step up method with menstruation. From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily. |
| Sildenafil and estradiol valerat | Experimental | Drug: Sildenafil, Drug: estradiol valeratOne of two group to prepare the endometrium give estradiol by step up method with menstruation. From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- women > 40 years old,
- history of endocrine disease
- Hysteroscopic surgery
- cardiovascular, renal and liver disease
- hypotension( blood pressure < 90/50)
Key exclusion criteria (7 listed)
- A total of 80 patients with antecedent of poor endometrial response and had frozen embryo included in this study all women must to be < 40 years old,
- no history of endocrine disease,
- no Hysteroscopic surgery, had a high quality embryos no cardiovascular,
- renal and liver disease and
- no hypotension (blood pressure < 90/50) or
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 |
|---|---|---|
| Sildenafilsildenafil tablets(50 mg) daily | Drug | Sildenafil and estradiol valerat, sildenafil |
| estradiol valerat | Drug | Sildenafil and estradiol valerat |
Primary outcome
estimate the result of sildenafil on ultrasonographic endometrial thickness
Time frame: between 2009-2011 (up to 2 years)
Assays: Day 13 of menstrual cycle endometrial thickness estimated with Transvaginal ultrasonographic(arranged in a series every other day), evaluations were performed by a single investigator, If the endometrial thickness is more than 8mm progesterone injected 100 mg intramuscular and Estrogen, progesterone and lh measured in blood sample then after three days embryo transferred.
1 secondary outcome
estimate the result of sildenafil on Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .
Time frame: between 2009-2011 (up to 2 years)
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 13 Sep 2012.
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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.
farzaneh hojjat, MD principal investigator
Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science, Bouali Ave. Safaieh, Yazd,Iran.
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 Sildenafil and estradiol valerat in people with Endometrial Preparation and Frozen Embryo Transfer, run by farzaneh hojjat at 1 site in Iran.
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 7 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 13 Sep 2012. 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 Iran. 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?
estimate the result of sildenafil on ultrasonographic endometrial thickness (time frame: between 2009-2011 (up to 2 years)). 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 13 Sep 2012.