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

NCT01668446 | Completed Phase 4 DMC

• 2 other identifiers: radvin123rad123
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Endometrial Preparation; Frozen Embryo Transfer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• estimate the result of sildenafil on Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .

  between 2009-2011 (up to 2 years)

Study Arms (2)

sildenafil

EXPERIMENTAL

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 and estradiol valerat

EXPERIMENTAL

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; Drug: estradiol valerat

Interventions

Sildenafil DRUG

sildenafil tablets(50 mg) daily

Sildenafil and estradiol valerat; sildenafil

estradiol valerat DRUG

Sildenafil and estradiol valerat

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• farzaneh hojjat: lead
• Razieh dehghani firouzabadi: collaborator
• Robab davar: collaborator

Study Sites (1)

Farzaneh Hojjat

Yazd, 8916878466, Iran

Location

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Farzaneh hojjat MD

Study Record Dates

• First Submitted: June 24, 2012
• First Posted: August 20, 2012
• Study Start: September 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2011
• Last Updated: September 13, 2012

Record last verified: 2012-09

Locations

IR (1)