The Effect of Sildenafil Citrate on Frozen Embryo Transfer Cycles

NCT05951413 | Unknown Phase 2

• 1 other identifier: frozen embryo tansfer 1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

to investigate the value of adding sildenafil citrate during endometrial preparation in patients undergoing frozen-thawed embryo transfer and its effect on endometrial thickness and pregnancy rates.

Conditions

IVF

Keywords

Sildenafil; thawed embryo transfer; endometrial thickness

Outcome Measures

Primary Outcomes (1)

• endometrial thickness

  endometrial thickness measured by transvaginal ultrasound

  10 to 16 days from start of cycle

Secondary Outcomes (1)

• pregnancy rate

  1 month

Study Arms (2)

Sildenafil

EXPERIMENTAL

patients will be given estradiol in form of Cycloprogynova 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 and will have will be given sildenafil citrate tablets (50 mg) daily .

Drug: Sildenafil Citrate; Drug: estradiol

control

PLACEBO COMPARATOR

patients will be given estradiol in form of Cycloprogynova 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

Interventions

Sildenafil Citrate DRUG

a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5),

Also known as: respatio, Viagra

Sildenafil

estradiol DRUG

estradiol in form of Cycloprogynova 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

Sildenafil; control

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age under 40 years
• Subject has high quality frozen embryos

You may not qualify if:

• A history of endocrine diseases. 2. A history of any previous surgery that could compromise the integrity of endometrium.
• \. Cardiovascular, renal and liver diseases. 4. Hypotension (blood pressure less than 90/50). 5. A history of stroke or myocardial infarction. 6. A history of previous implantation failure.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

RECRUITING

MeSH Terms

Interventions

Sildenafil Citrate; Estradiol

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Beni-Suef University

  Faculty of Medicine Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara A Salem, MD

CONTACT

01272842226; sara_abdallah100@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: July 19, 2023
• Study Start: June 30, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

EG (1)