NCT07499804

Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

investigate the effect of different vasodilators as Tadalafil in women with unexplained infertility using IVF

Detailed description

This prospective randomized clinical study was carried out on 100 women, aged \<18 to 43 years old, has good quality day five frozen embryos. The study was done after approval from the Ethical Committee Beni Suef University Hospitals, Beni Suef, Egypt. An informed written consent was obtained from the patients. Randomization and blindness: An online randomization program (http://www.randomizer.org ) was used to generate a random list and each patient's code was kept in an opaque sealed envelope. Patients were randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner: Group 1 (control): Patients received estradiol valerate 2 mg. in form of (Cycloprogynova® Bayer Shering Pharma) 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: received tadalafil 5 mg. once daily in form of (tadanerfi 5® Nerhadou international5 co.) daily in addition to the above treatment protocol from the first day of the cycle until the day of starting progesterone. All patients were subjected to complete history taking, general examination, laboratory investigations \[Anti-müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E₂), prolactin (PRL) and thyroid-stimulating hormone (TSH)\] and radiological investigations \[Ultrasonography\].

Conditions

• IVF
• Infertility, Female

Interventions

Type	Name	Description
DRUG	Tadalafil 5mg	phosphodiesterase type 5 (PDE-5) inhibitor
DRUG	estradiol valerate 2 mg	estradiol valerate 2 mg. in form of (Cycloprogynova® Bayer Shering Pharma) 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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Egypt