Tadalafil to increase uterine lining and improve frozen embryo transfer success
Official title: Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes
Run by Beni-Suef University · NCT07499804 · Data updated 2026-11-12
This test sees if adding daily tadalafil to standard estrogen helps women with unexplained infertility using good-quality day‑5 frozen embryos get a thicker uterine lining and better transfer outcomes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 43 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Banī Suwayf, Beni Suweif Governorate) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | April 30, 2026 |
| Study ends | April 30, 2026 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT07499804 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women roughly 18–43 years old with unexplained infertility who have good-quality day‑5 frozen embryos, normal blood pressure, and can attend the Beni-Suef site are the ideal candidates.
✕Probably not a fit
Patients with low blood pressure (under 90/50), a history of stroke or myocardial infarction, significant cardiovascular disease, or those without day‑5 frozen embryos are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, prospective Phase 4 study enrolled 100 women aged 18–43 with good-quality day‑5 frozen embryos at Beni-Suef University Hospital in Egypt. Participants were randomized 1:1 to receive standard estradiol valerate for endometrial preparation with or without tadalafil 5 mg daily from cycle day 1 until the start of progesterone. Endometrial thickness was measured by transvaginal ultrasound (including a day‑9 check) and baseline hormone testing (AMH, FSH, LH, estradiol, prolactin, TSH) was performed. Allocation used opaque sealed envelopes for concealment and no additional blinding is described.
Why it matters
Potential benefit: If successful, adding tadalafil could thicken the endometrium and increase pregnancy or implantation rates after frozen embryo transfer for selected patients.
How similar studies have gone: Prior small trials and case series using PDE5 inhibitors such as sildenafil or tadalafil for endometrial enhancement have shown mixed but sometimes promising results, so the approach remains not definitively proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * has good quality day five frozen embryos. Exclusion Criteria: * hypotension (blood pressure less than 90/50) and * history of stroke or myocardial infarction
Where it's running
-
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Sara A Salem
- Email: sara.abdalla@med.bsu.edu.eg
- Phone: 01272842226
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.