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Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07499804
Enrollment
100
Registered
2026-03-30
Start date
2023-10-01
Completion date
2026-04-30
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IVF, Infertility, Female

Brief 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 \[Ultrasonography\].

Interventions

phosphodiesterase type 5 (PDE-5) inhibitor

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.

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pregnancy1 monthwhom Beta-Human Chorionic Gonadotropin (β-hCG) was positive

Countries

Egypt

Contacts

CONTACTSara A Salem
sara.abdalla@med.bsu.edu.eg01272842226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026