Sildenafil Citrate in Frozen Embryo Transfer

July 26, 2016 updated by: Omar Ahmed El Sayed Saad

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

Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: estradiol valerate
estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more
Drug: estradiol valerate
Active Comparator: Sildenafil citrate and estradiol valerate
Sildenafil citrate 25 mg every 6 hours orally in combination with estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more
Drug: Sildenafil citrate
Other Names:
  • Viagra
Drug: estradiol valerate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endometrial pattern
Time Frame: starting from 8th day till 12th day of the menstrual cycle
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endometrial thickness
Time Frame: starting from 8th day till 12th day of menstrual cycle
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
biochemical pregnancy test
Time Frame: 2 weeks after embryo transfer
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omar Ahmed El Sayed Saad

Investigators

  • Study Chair: Alaa mohamed elghannam, professor, department of obstetric and gynacology Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ainshams2015Omar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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