Sildenafil Citrate in Frozen Embryo Transfer

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845388
• Other study ID #: Ainshams2015Omar
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2016
• Last updated: July 26, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ministry of health and population of egypt':'
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Sildenafil citrate

• estradiol valerate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Omar Ahmed El Sayed Saad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No