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NCT Number: NCT07499804

Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

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

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Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location status: Recruiting

Location contact

Beni Suef University

CONTACT

[email protected]

082 2356845 ext. 2

About this study

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].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tadalafil 5mg

Drug

phosphodiesterase type 5 (PDE-5) inhibitor

estradiol valerate 2 mg

Drug

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.

Other names: Cycloprogynova®

Primary outcomes

  1. pregnancy

    Time frame: 1 month

    whom Beta-Human Chorionic Gonadotropin (β-hCG) was positive

Study contacts

Contact information is provided by the study sponsor or research team.

Sara A Salem

CONTACT

[email protected]

01272842226 ext. 02

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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