Tadalafil to increase uterine lining and improve frozen embryo transfer success

Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

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
• Enrollment: 100 (estimated)
• Ages: 18 Years to 43 Years
• Sex: Female
• Sponsor: Beni-Suef University (Academic / other)
• Locations: 1 site (Banī Suwayf, Beni Suweif Governorate)
• Trial ID: NCT07499804 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Banī Suwayf, Beni Suweif Governorate

• Beni-suef university Hospital — Banī Suwayf, Beni Suweif Governorate, Egypt (Recruiting)

Study contacts

• Study coordinator: Sara A Salem

Conditions IVF; Infertility, Female