The Effect of Sildenafil Citrate on Frozen Embryo Transfer Cycles

The Effect of Sildenafil Citrate on the Endometrial Thickness and Pregnancy Rates of Frozen Embryo Transfer Cycles

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.

Study Overview

• Status: Recruiting
• Conditions: IVF
• Intervention / Treatment: Drug: Sildenafil Citrate; Drug: estradiol

Detailed Description

Patients who met these conditions entered the study and 110 patients will be divided into two groups 55 patients in each group based on randomized tables.

Group 1: 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.

Group 2: will be given sildenafil citrate tablets (50 mg) daily in addition to the above treatment protocol from the first day of the cycle until the day of starting progesterone. It was discontinued 48- 72 hours prior to the embryo transfer.

On the ninth day of the menstrual cycle, the endometrial thickness will be estimated by transvaginal ultrasonography (arranged in a series every other day). The evaluations will be performed by a single investigator.

If the endometrial thickness was more than 8mm, 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered.

If the endometrial thickness is less than 8 mm estrogen dosage will be increased to two pills t.i.d and patients would be arranged for follow up every other day for endometrial thickness estimation by transvaginal ultrasound till endometrial thickness is more than 8 mm , then 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered.

Frozen thawed embryo transfer will be carried out after 5 days (blastocyst stage). Estrogen and progesterone will be continued until two weeks after the embryos are transferred. In cases whom BHCG would be positive, estrogen and progesterone will be continued until the 11th week of pregnancy.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sara A Salem, MD; Phone Number: 02 01272842226; Email: sara_abdallah100@yahoo.com

Study Locations

• Egypt
  • Beni Suef
    • Banī Suwayf, Beni Suef, Egypt, 62521
      • Recruiting
      • Beni-suef university Hospital
      • Contact: Beni Suef University; Phone Number: 2 082 2356845; Email: info@bsu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age under 40 years
2. Subject has high quality frozen embryos

Exclusion Criteria:

1-A history of endocrine diseases. 2. A history of any previous surgery that could compromise the integrity of endometrium.

3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sildenafil; 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; a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5),; Other Names: Viagra; respatio; Drug: estradiol; 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.; Other Names: Cycloprogynova
Placebo Comparator: control; 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; 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.; Other Names: Cycloprogynova

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endometrial thickness	endometrial thickness measured by transvaginal ultrasound	10 to 16 days from start of cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy rate	the number of patients who get pregnant measured by HCG test positive	1 month

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Beni-Suef University, Faculty of medicine Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: July 16, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 16, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Sildenafil; endometrial thickness; thawed embryo transfer
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Estradiol; Sildenafil Citrate
• Other Study ID Numbers: frozen embryo tansfer 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No