Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

NCT07499804 | Recruiting Phase 4 DMC

• 1 other identifier: Tadafil/IVF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IVF; Infertility, Female

Outcome Measures

Primary Outcomes (1)

• pregnancy

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

  1 month

Study Arms (2)

(control)

ACTIVE COMPARATOR

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.

Drug: estradiol valerate 2 mg

tadalafil 5 mg

EXPERIMENTAL

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

Drug: Tadalafil 5mg

Interventions

Tadalafil 5mg DRUG

phosphodiesterase type 5 (PDE-5) inhibitor

tadalafil 5 mg

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.

Also known as: Cycloprogynova®

(control)

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• has good quality day five frozen embryos.

You may not qualify if:

• hypotension (blood pressure less than 90/50) and
• history of stroke or myocardial infarction

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

Tadalafil; Estradiol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Sara A Salem

CONTACT

01272842226; sara.abdalla@med.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of obstetrics and gynecology

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 30, 2026
• Study Start: October 1, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

EG (1)