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

This study has been completed.
Sponsor:
Collaborators:
Razieh dehghani firouzabadi
Robab davar
Information provided by (Responsible Party):
farzaneh hojjat, Shahid Sadoughi University of Medical Sciences and Health Services
ClinicalTrials.gov Identifier:
NCT01668446
First received: June 24, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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 .


Condition Intervention Phase
Endometrial Preparation
Frozen Embryo Transfer
Drug: Sildenafil
Drug: estradiol valerat
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles

Resource links provided by NLM:


Further study details as provided by Shahid Sadoughi University of Medical Sciences and Health Services:

Primary Outcome Measures:
  • estimate the result of sildenafil on ultrasonographic endometrial thickness [ Time Frame: between 2009-2011 (up to 2 years) ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • estimate the result of sildenafil on Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles . [ Time Frame: between 2009-2011 (up to 2 years) ] [ Designated as safety issue: Yes ]
    Implantation rate was higher in sildenafil Group but not significant chemical pregnancy rates were higher in sildenafil Group but not significant.


Enrollment: 2
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: Sildenafil
sildenafil tablets(50 mg) daily
Experimental: 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.

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

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01668446

Locations
Iran, Islamic Republic of
Farzaneh Hojjat
Yazd, Iran, Islamic Republic of, 8916878466
Sponsors and Collaborators
farzaneh hojjat
Razieh dehghani firouzabadi
Robab davar
Investigators
Principal Investigator: farzaneh hojjat, MD Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science, Bouali Ave. Safaieh, Yazd,Iran.
  More Information

No publications provided

Responsible Party: farzaneh hojjat, Farzaneh hojjat MD, Shahid Sadoughi University of Medical Sciences and Health Services
ClinicalTrials.gov Identifier: NCT01668446     History of Changes
Other Study ID Numbers: radvin123, rad123, rad123
Study First Received: June 24, 2012
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Shahid Sadoughi University of Medical Sciences and Health Services:
Sildenafil
Endometrial thickness
Frozen embryo transfer
ultrasonographic endometrial thickness
endometrial pattern
Implantation rate
chemical pregnancy rate

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Sildenafil
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014