IVFPhase 2/3NCT05951413
The Effect of Sildenafil Citrate on Frozen Embryo Transfer Cycles
A Phase 2/3 study testing Sildenafil Citrate and estradiol in people with IVF, run by Beni-Suef University at 1 site in Egypt.
Trial summary
to investigate the value of adding sildenafil citrate during endometrial preparation in patients undergoing frozen-thawed embryo transfer and its effect on endometrial thickness and pregnancy rates. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- Sildenafil Citrate and estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2023to 30 Sep 2023
- Phase
- Phase 2/3
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age under 40 years
- Subject has high quality frozen embryos
Who cannot join
- 1-A history of endocrine diseases. 2. A history of any previous surgery that could compromise the integrity of endometrium.
- 3. Cardiovascular, renal and liver diseases. 4. Hypotension (blood pressure less than 90/50). 5. A history of stroke or myocardial infarction. 6. A history of previous implantation failure.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
Beni Suef University, 082 2356845 ext. 2, info@bsu.edu.eg
About this study
Official title: The Effect of Sildenafil Citrate on the Endometrial Thickness and Pregnancy Rates of Frozen Embryo Transfer Cycles
to investigate the value of adding sildenafil citrate during endometrial preparation in patients undergoing frozen-thawed embryo transfer and its effect on endometrial thickness and pregnancy rates.
Read the detailed description
Patients who met these conditions entered the study and 110 patients will be divided into two groups 55 patients in each group based on randomized tables.
Group 1: will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound.
Group 2: will be given sildenafil citrate tablets (50 mg) daily in addition to the above treatment protocol from the first day of the cycle until the day of starting progesterone. It was discontinued 48- 72 hours prior to the embryo transfer.
On the ninth day of the menstrual cycle, the endometrial thickness will be estimated by transvaginal ultrasonography (arranged in a series every other day). The evaluations will be performed by a single investigator.
If the endometrial thickness was more than 8mm, 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered.
If the endometrial thickness is less than 8 mm estrogen dosage will be increased to two pills t.i.d and patients would be arranged for follow up every other day for endometrial thickness estimation by transvaginal ultrasound till endometrial thickness is more than 8 mm , then 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered.
Frozen thawed embryo transfer will be carried out after 5 days (blastocyst stage). Estrogen and progesterone will be continued until two weeks after the embryos are transferred. In cases whom BHCG would be positive, estrogen and progesterone will be continued until the 11th week of pregnancy.
- Conditions
- IVF
- Being tested
- Sildenafil Citrate, estradiol
- Keywords
- Sildenafil, thawed embryo transfer, endometrial thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil CitrateDrug
Also called respatio, Viagra
a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5),
estradiolDrug
Also called Cycloprogynova
estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | patients will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound and will have will be given sildenafil citrate tablets (50 mg) daily . Receives: Drug: Sildenafil Citrate; Drug: estradiol |
| control | Placebo comparator | patients will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound. Receives: Drug: estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial thickness
endometrial thickness measured by transvaginal ultrasound
Measured: 10 to 16 days from start of cycle
Secondary outcomes (1)
pregnancy rate
the number of patients who get pregnant measured by HCG test positive
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start30 Jun 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
- Investigators
- Beni-Suef University, Principal investigator, Faculty of Medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951413
- Sponsor's protocol ID
- frozen embryo tansfer 1
- Status last verified
- Jul 2023
- First submitted
- 4 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sildenafil Citrate on the Endometrial Thickness and Pregnancy Rates of Frozen Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT05951413
- Acronym / sponsor ID
- frozen embryo tansfer 1
- Conditions
- IVF
- Keywords
- Sildenafil, thawed embryo transfer, endometrial thickness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 19 Jul 2023 (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.
to investigate the value of adding sildenafil citrate during endometrial preparation in patients undergoing frozen-thawed embryo transfer and its effect on endometrial thickness and pregnancy rates.
Detailed description
Patients who met these conditions entered the study and 110 patients will be divided into two groups 55 patients in each group based on randomized tables.
Group 1: will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound.
Group 2: will be given sildenafil citrate tablets (50 mg) daily in addition to the above treatment protocol from the first day of the cycle until the day of starting progesterone. It was discontinued 48- 72 hours prior to the embryo transfer.
On the ninth day of the menstrual cycle, the endometrial thickness will be estimated by transvaginal ultrasonography (arranged in a series every other day). The evaluations will be performed by a single investigator.
If the endometrial thickness was more than 8mm, 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered.
If the endometrial thickness is less than 8 mm estrogen dosage will be increased to two pills t.i.d and patients would be arranged for follow up every other day for endometrial thickness estimation by transvaginal ultrasound till endometrial thickness is more than 8 mm , then 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered.
Frozen thawed embryo transfer will be carried out after 5 days (blastocyst stage). Estrogen and progesterone will be continued until two weeks after the embryos are transferred. In cases whom BHCG would be positive, estrogen and progesterone will be continued until the 11th week of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: Sildenafil Citrate, Drug: estradiolpatients will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound and will have will be given sildenafil citrate tablets (50 mg) daily . |
| control | Placebo comparator | Drug: estradiolpatients will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age under 40 years
- Subject has high quality frozen embryos
Key exclusion criteria (2 listed)
- 1-A history of endocrine diseases. 2. A history of any previous surgery that could compromise the integrity of endometrium.
- 3. Cardiovascular, renal and liver diseases. 4. Hypotension (blood pressure less than 90/50). 5. A history of stroke or myocardial infarction. 6. A history of previous implantation 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 |
|---|---|---|
| Sildenafil CitrateAlso: respatio, Viagraa potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), | Drug | Sildenafil |
| estradiolAlso: Cycloprogynovaestradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound. | Drug | Sildenafil, control |
Primary outcome
endometrial thickness
Time frame: 10 to 16 days from start of cycle
endometrial thickness measured by transvaginal ultrasound
1 secondary outcome
pregnancy rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- 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.
Beni-Suef University principal investigator
Faculty of Medicine Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sildenafil Citrate and estradiol in people with IVF, run by Beni-Suef 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 2 inclusion and 2 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 19 Jul 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sara A Salem, MD (01272842226 ext. 02, sara_abdallah100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial thickness (time frame: 10 to 16 days from start of 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 19 Jul 2023.