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Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles

NCT ID: NCT01668446

Last Updated: 2012-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-02-28

Brief Summary

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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 .

Detailed Description

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Conditions

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Endometrial Preparation Frozen Embryo Transfer

Keywords

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Sildenafil Endometrial thickness Frozen embryo transfer ultrasonographic endometrial thickness endometrial pattern Implantation rate chemical pregnancy rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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sildenafil

One of two group to prepare the endometrium give estradiol by step up method with menstruation.

From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily.

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

sildenafil tablets(50 mg) daily

Sildenafil and estradiol valerat

One of two group to prepare the endometrium give estradiol by step up method with menstruation.

From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily.

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

sildenafil tablets(50 mg) daily

estradiol valerat

Intervention Type DRUG

Interventions

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Sildenafil

sildenafil tablets(50 mg) daily

Intervention Type DRUG

estradiol valerat

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Razieh dehghani firouzabadi

UNKNOWN

Sponsor Role collaborator

Robab davar

UNKNOWN

Sponsor Role collaborator

farzaneh hojjat

OTHER

Sponsor Role lead

Responsible Party

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farzaneh hojjat

Farzaneh hojjat MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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farzaneh hojjat, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science, Bouali Ave. Safaieh, Yazd,Iran.

Locations

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Farzaneh Hojjat

Yazd, , Iran

Site Status

Countries

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Iran

Other Identifiers

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rad123

Identifier Type: OTHER

Identifier Source: secondary_id

rad123

Identifier Type: OTHER

Identifier Source: secondary_id

radvin123

Identifier Type: -

Identifier Source: org_study_id