Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tadalafil 5mg, estradiol valerate 2 mg.
- Who it may be relevant to
- Registry conditions: IVF, Infertility, Female. Basic parameters: 18 years — 43 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- pregnancy [Time frame: 1 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Beni-suef university Hospital — Banī Suwayf
Identifiers
NCT: NCT07499804 · Tadafil/IVF