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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01668446
Other study ID # radvin123
Secondary ID rad123rad123
Status Completed
Phase Phase 4
First received June 24, 2012
Last updated September 11, 2012
Start date September 2009
Est. completion date February 2011

Study information

Verified date September 2012
Source Shahid Sadoughi University of Medical Sciences and Health Services
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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 .


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date February 2011
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 39 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Sildenafil
sildenafil tablets(50 mg) daily
estradiol valerat


Locations

Country Name City State
Iran, Islamic Republic of Farzaneh Hojjat Yazd

Sponsors (3)

Lead Sponsor Collaborator
farzaneh hojjat Razieh dehghani firouzabadi, Robab davar

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Yes
Secondary 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) Yes
See also
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Recruiting NCT06239376 - Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients N/A
Completed NCT01943812 - Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation Phase 4
Active, not recruiting NCT05555121 - Rescue Progesterone Supplementation During Frozen Embryo Transfer Phase 2
Withdrawn NCT05168865 - Letrozole Versus Hormonal Preparation in Frozen Cycles of PCOS Patients. Phase 4