Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles (sildenafil)

The target of this study was an estimate the result of sildenafil on ultrasonographic endometrial thickness, endometrial pattern investigation estrogen level on the day of progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .

Study Overview

• Status: Completed
• Conditions: Frozen Embryo Transfer; Endometrial Preparation
• Intervention / Treatment: Drug: Sildenafil; Drug: estradiol valerat

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Yazd, Iran, Islamic Republic of, 8916878466
    • Farzaneh Hojjat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women > 40 years old,
• history of endocrine disease
• Hysteroscopic surgery
• cardiovascular, renal and liver disease
• hypotension( blood pressure < 90/50)
• history of stroke or myocardial infarction
• use of alcohol or substance

Exclusion Criteria:

A total of 80 patients with antecedent of poor endometrial response and had frozen embryo included in this study all women must to be < 40 years old,

• no history of endocrine disease,
• no Hysteroscopic surgery, had a high quality embryos no cardiovascular,
• renal and liver disease and
• no hypotension (blood pressure < 90/50) or
• history of stroke or myocardial infarction and
• don't use of alcohol or substance Patients with these conditions enter this study and based on randomized tables are divided in two groups.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sildenafil; One of two group to prepare the endometrium give estradiol by step up method with menstruation. From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily.	Drug: Sildenafil; sildenafil tablets(50 mg) daily
Experimental: Sildenafil and estradiol valerat; One of two group to prepare the endometrium give estradiol by step up method with menstruation. From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily.	Drug: Sildenafil; sildenafil tablets(50 mg) daily; Drug: estradiol valerat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimate the result of sildenafil on ultrasonographic endometrial thickness	Assays: Day 13 of menstrual cycle endometrial thickness estimated with Transvaginal ultrasonographic(arranged in a series every other day), evaluations were performed by a single investigator, If the endometrial thickness is more than 8mm progesterone injected 100 mg intramuscular and Estrogen, progesterone and lh measured in blood sample then after three days embryo transferred.	between 2009-2011 (up to 2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimate the result of sildenafil on Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .	Implantation rate was higher in sildenafil Group but not significant chemical pregnancy rates were higher in sildenafil Group but not significant.	between 2009-2011 (up to 2 years)

Collaborators and Investigators

• Sponsor: farzaneh hojjat
• Collaborators: Razieh dehghani firouzabadi; Robab davar
• Investigators: Principal Investigator: farzaneh hojjat, MD, Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science, Bouali Ave. Safaieh, Yazd,Iran.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: June 24, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 20, 2012

Study Record Updates

• Last Update Posted (Estimate): September 13, 2012
• Last Update Submitted That Met QC Criteria: September 11, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Frozen embryo transfer; Sildenafil; Implantation rate; Endometrial thickness; ultrasonographic endometrial thickness; endometrial pattern; chemical pregnancy rate
• 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: radvin123; rad123 (Other Identifier: Shahid Sadoughi University of Medical Science, Bouali Ave. Safaieh, Yazd,Iran.)