Actively Recruiting

Phase 4
Age: 18Years - 43Years
FEMALE
ID07499804

Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

Led by Beni-Suef University · Updated on 2026-03-30

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of different vasodilators, specifically Tadalafil, on women experiencing unexplained infertility who are undergoing in vitro fertilization (IVF). This study involves women aged 18 to 43 years who have good quality day five frozen embryos and aims to understand how Tadalafil influences endometrial thickness and pregnancy outcomes following frozen embryo transfer. The research is a prospective, randomized clinical trial approved by the Ethical Committee at Beni Suef University Hospitals in Egypt. Participants are randomly assigned into two groups. The control group receives estradiol valerate 2 mg tablets, starting with one pill three times daily, which may be increased based on endometrial thickness measured by vaginal ultrasound on day 9. The experimental group receives the same estradiol valerate treatment plus a daily dose of Tadalafil 5 mg starting from the first day of the cycle until the day progesterone treatment begins. Both treatments are studied in parallel to assess their effects. Throughout the study, all patients undergo detailed history taking, general and laboratory examinations including hormone levels (AMH, FSH, LH, estradiol, prolactin, and TSH), and ultrasound imaging. The primary outcome measured is pregnancy status one month after treatment. The trial monitors the participants closely from the start of the cycle through embryo transfer and early pregnancy evaluation, with all procedures conducted under ethical approval and informed consent.

CONDITIONS

Brief Title

Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

Who Can Participate

Age: 18Years - 43Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 18 to 43 years
  • Good quality day five frozen embryos available
Not Eligible

You will not qualify if you...

  • Hypotension with blood pressure less than 90/50 mmHg
  • History of stroke or myocardial infarction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - From first day of cycle until starting progesterone

Participants receive estradiol valerate pills starting on day 1 of their cycle, with dose adjustments based on ultrasound measurements on day 9. Some participants also take tadalafil 5 mg daily from cycle day 1 until starting progesterone.

At least 2 visits including day 9 ultrasound and progesterone start visit

Trial Site Locations

Total: 1 location

1

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt, 62521

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Research Team

S

Sara A Salem

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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