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

Frozen Embryo Transfer Clinical Trial

— sildenafil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668446
• Other study ID #: radvin123
• Secondary ID: rad123rad123
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2012
• Last updated: September 11, 2012
• Start date: September 2009
• Est. completion date: February 2011

Study information

• Verified date: September 2012
• Source: Shahid Sadoughi University of Medical Sciences and Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: February 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Preparation
• Frozen Embryo Transfer

Intervention

Drug:
• Sildenafil
sildenafil tablets(50 mg) daily
• estradiol valerat

Locations

Country	Name	City	State
Iran, Islamic Republic of	Farzaneh Hojjat	Yazd

Sponsors (3)

Lead Sponsor	Collaborator
farzaneh hojjat	Razieh dehghani firouzabadi, Robab davar

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes