Sildenafil Citrate in Frozen Embryo Transfer

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: Sildenafil citrate; Drug: estradiol valerate

• Registration Number: NCT02845388
• Lead Sponsor: Omar Ahmed El Sayed Saad

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-27
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil citrate and estradiol valerate	Sildenafil citrate	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
estradiol valerate	estradiol valerate	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
Sildenafil citrate and estradiol valerate	estradiol valerate	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

Primary Outcome Measures

Name	Time	Method
endometrial pattern	starting from 8th day till 12th day of the menstrual cycle	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.

Secondary Outcome Measures

Name	Time	Method
endometrial thickness	starting from 8th day till 12th day of menstrual cycle	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.
biochemical pregnancy test	2 weeks after embryo transfer	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.