Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

Beni-Suef University

Status and phase: Enrolling; Phase 4

Conditions: IVF; Infertility, Female

Treatments: Drug: Tadalafil 5mg; Drug: estradiol valerate 2 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07499804

Tadafil/IVF

Details and patient eligibility

About

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

Full 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].

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

(control)

Active Comparator group

Description:

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.

Treatment:

Drug: estradiol valerate 2 mg

tadalafil 5 mg

Experimental group

Description:

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

Treatment:

Drug: Tadalafil 5mg