The Effect of Sildenafil Citrate on Frozen Embryo Transfer Cycles

Study Overview
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Brief Summary
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to investigate the value of adding sildenafil citrate during endometrial preparation in patients undergoing frozen-thawed embryo transfer and its effect on endometrial thickness and pregnancy rates.

Detailed Description
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Patients who met these conditions entered the study and 110 patients will be divided into two groups 55 patients in each group based on randomized tables. Group 1: will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound. Group 2: will be given sildenafil citrate tablets (50 mg) daily in addition to the above treatment protocol from the first day of the cycle until the day of starting progesterone. It was discontinued 48- 72 hours prior to the embryo transfer. On the ninth day of the menstrual cycle, the endometrial thickness will be estimated by transvaginal ultrasonography (arranged in a series every other day). The evaluations will be performed by a single investigator. If the endometrial thickness was more than 8mm, 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered. If the endometrial thickness is less than 8 mm estrogen dosage will be increased to two pills t.i.d and patients would be arranged for follow up every other day for endometrial thickness estimation by transvaginal ultrasound till endometrial thickness is more than 8 mm , then 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered. Frozen thawed embryo transfer will be carried out after 5 days (blastocyst stage). Estrogen and progesterone will be continued until two weeks after the embryos are transferred. In cases whom BHCG would be positive, estrogen and progesterone will be continued until the 11th week of pregnancy.

Official Title
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The Effect of Sildenafil Citrate on the Endometrial Thickness and Pregnancy Rates of Frozen Embryo Transfer Cycles

Conditions
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IVF

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age under 40 years Subject has high quality frozen embryos Exclusion Criteria: 1-A history of endocrine diseases. 2. A history of any previous surgery that could compromise the integrity of endometrium. 3. Cardiovascular, renal and liver diseases. 4. Hypotension (blood pressure less than 90/50). 5. A history of stroke or myocardial infarction. 6. A history of previous implantation failure.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildenafil<br>patients will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound and will have will be given sildenafil citrate tablets (50 mg) daily . | Drug: Sildenafil Citrate<br>* a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5),<br>* Other names: Viagra;Drug: estradiol<br>* estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound.<br>* Other names: Cycloprogynova;|
| Placebo Comparator: control<br>patients will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound. | Drug: estradiol<br>* estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound.<br>* Other names: Cycloprogynova;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial thickness | endometrial thickness measured by transvaginal ultrasound | 10 to 16 days from start of cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | the number of patients who get pregnant measured by HCG test positive | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sildenafil, thawed embryo transfer, endometrial thickness