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

Study Overview
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Brief Summary
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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 .

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

Conditions
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Endometrial Preparation, Frozen Embryo Transfer

Intervention / Treatment
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* Drug: Sildenafil
* Drug: estradiol valerat


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sildenafil<br>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<br>* sildenafil tablets(50 mg) daily<br>|
| Experimental: Sildenafil and estradiol valerat<br>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<br>* sildenafil tablets(50 mg) daily<br>Drug: estradiol valerat<br> <br> |

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sildenafil, Endometrial thickness, Frozen embryo transfer, ultrasonographic endometrial thickness, endometrial pattern, Implantation rate, chemical pregnancy rate