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

Phase 4

Completed

• Conditions: Endometrial Preparation; Frozen Embryo Transfer
• Interventions: Drug: Sildenafil; Drug: estradiol valerat

• Registration Number: NCT01668446
• Lead Sponsor: farzaneh hojjat

Brief 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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2011-02
• Study First Submitted: 2012-06-24
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-20
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-11
• Last Update Posted: 2012-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sildenafil and estradiol valerat	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.
sildenafil	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.
Sildenafil and estradiol valerat	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.

Primary Outcome Measures

Name	Time	Method
estimate the result of sildenafil on ultrasonographic endometrial thickness	between 2009-2011 (up to 2 years)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Farzaneh Hojjat; 🇮🇷 Yazd, Iran, Islamic Republic of