Sildenafil Citrate in Frozen Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.

Official Title
-----------------
Sildenafil Citrate for Endometrial Preparation in Frozen-thawed Embryo Transfer Cycles

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Sildenafil citrate
* Drug: estradiol valerate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cases have at least 2 good quality blastocysts available for transfer Exclusion Criteria: uterine structural abnormalities advanced uterine disease hydrosalpinx and pyosalpinx

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 37 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: estradiol valerate<br>estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more | Drug: estradiol valerate<br> <br> |
| Active Comparator: Sildenafil citrate and estradiol valerate<br>Sildenafil citrate 25 mg every 6 hours orally in combination with estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more | Drug: Sildenafil citrate<br> <br> * Other names: Viagra;Drug: estradiol valerate<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial pattern | Endometrial pattern will be trilaminar or bilaminar after it's preparation with estradiol valerate alone or estradiol valerate and sildenafil citrate. Endometrial pattern will be estimated by transvaginal ultrasonography for trilaminar pattern every other day from 8th day till 12th day of the menstrual cycle. | starting from 8th day till 12th day of the menstrual cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial thickness | Endometrial thickness will be estimated by transvaginal ultrasonography after it's preparation with estradiol valerate alone or estradiol valerate and sildenafil citrate for thickness 8 mm or more every other day from 8th day till 12th day of the menstrual cycle. | starting from 8th day till 12th day of menstrual cycle | 
| biochemical pregnancy test | Serum B,human chorionic gonadotropin subunit will be measured 2 weeks after embryo transfer which will be positive when it's level exceeds 5 milli international unit /milli litre in patient's serum. | 2 weeks after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF