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Effect of Vaginal Sildenafil Citrate on Endometrial Preparation and Outcome in Frozen Thawed Embryo Transfer Cycles

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sildenafil citrate
Estradiol Valerate 2 MG
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women undergoing their first frozen embryo transfer cycle.
  • have at least two high quality frozen embryos

Exclusion Criteria:

  • 1. a history of endocrine diseases. 2. a history of hysteroscopic surgeries. 3. cardiovascular, renal and liver diseases. 4. hypotension (blood pressure <90/50 mmHg). 5. a history of stroke or myocardial infarction.

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sildenafil group

estradiol group

Arm Description

40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle

40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium in addition to placebo in the same way as sildenafil

Outcomes

Primary Outcome Measures

endometrial thickness
ultrasound measurement of the endometrial thickness at the fundus

Secondary Outcome Measures

Endometrial vascularity
two dimension power Doppler characteristics as normal quality of color, color gain-3.4, pulse repetition frequency of 600Hz and wall motion filter of 50Hz are applied in all examinations. By following Applebaum's zones of vascularity for categorizing endometrial vasculaity: Zone 1 vascularity-When blood vessls reach the hypoechoic endometrio-myometria junction, Zone 2 vascularity when the vessels reach the outer hyperechoic line of en-dometrium, Zone 3 vascularity when it reach the intervening hypoechoic area, Zone 4 vascularity when the vessels are seen reaching the central echogenic line
clinical pregnancy rate
detection of intrauterine gestational sac by transvaginal ultrasound

Full Information

First Posted
February 23, 2019
Last Updated
February 23, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03854175
Brief Title
Effect of Vaginal Sildenafil Citrate on Endometrial Preparation and Outcome in Frozen Thawed Embryo Transfer Cycles
Official Title
Effect of Vaginal Sildenafil Citrate on Endometrial Preparation and Outcome in Frozen Thawed Embryo Transfer Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A total of 80 Patients who meet these conditions will enter the study and be divided into two groups based on randomized tables. To prepare the endometrium, Group A : 40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium Group B : 40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle . Estrogen and progesterone (prontogest 400mg pessaries ) are given 3 days prior to embryo transfer. Sildenafil is discontinued 48-72 hours prior to the embryo transfe due sildenafil may have some detrimental effects on endometrium in the implantation window
Detailed Description
A total of 80 Patients who meet these conditions will enter the study and be divided into two groups based on randomized tables. To prepare the endometrium, Group A : 40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium Group B : 40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle . Estrogen and progesterone (prontogest 400mg pessaries ) are given 3 days prior to embryo transfer. Sildenafil is discontinued 48-72 hours prior to the embryo transfe due sildenafil may have some detrimental effects on endometrium in the implantation window. For assessing endometrial vascularity (on day 14 of cycle), two dimension power Doppler characteristics as normal quality of color, color gain-3.4, pulse repetition frequency of 600Hz and wall motion filter of 50Hz are applied in all examinations. By following Applebaum's zones of vascularity for categorizing endometrial vasculaity: Zone 1 vascularity-When blood vessls reach the hypoechoic endometrio-myometria junction, Zone 2 vascularity when the vessels reach the outer hyperechoic line of en-dometrium, Zone 3 vascularity when it reach the intervening hypoechoic area, Zone 4 vascularity when the vessels are seen reaching the central echogenic line . After 5 days when the endometrial pattern is triple line pattern (trilaminar) and endometrial thickness is more than 8mm,embryos will be transferred. All patients have a luteal phase support by giving a daily doses of estradiol valerat 2mg oral daily and 100mg progesterone (prontogest 100mg ampoule ) as an intramuscular which will be continued two weeks after the em-bryos transfer. In case BHCG is tested and proved to be positive, estradiol valerat and progesterone are continueed until the 11th week of pregnancy. Then, four weeks after the embryo transfer, the number of gestational sacs are determined by vaginal ultrasound.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sildenafil group
Arm Type
Active Comparator
Arm Description
40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle
Arm Title
estradiol group
Arm Type
Active Comparator
Arm Description
40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium in addition to placebo in the same way as sildenafil
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate
Intervention Description
25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle
Intervention Type
Drug
Intervention Name(s)
Estradiol Valerate 2 MG
Intervention Description
2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium
Primary Outcome Measure Information:
Title
endometrial thickness
Description
ultrasound measurement of the endometrial thickness at the fundus
Time Frame
At the day of embryo transfer
Secondary Outcome Measure Information:
Title
Endometrial vascularity
Description
two dimension power Doppler characteristics as normal quality of color, color gain-3.4, pulse repetition frequency of 600Hz and wall motion filter of 50Hz are applied in all examinations. By following Applebaum's zones of vascularity for categorizing endometrial vasculaity: Zone 1 vascularity-When blood vessls reach the hypoechoic endometrio-myometria junction, Zone 2 vascularity when the vessels reach the outer hyperechoic line of en-dometrium, Zone 3 vascularity when it reach the intervening hypoechoic area, Zone 4 vascularity when the vessels are seen reaching the central echogenic line
Time Frame
At the day of embryo transfer
Title
clinical pregnancy rate
Description
detection of intrauterine gestational sac by transvaginal ultrasound
Time Frame
4 weeks after embryo transfer

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women undergoing their first frozen embryo transfer cycle. have at least two high quality frozen embryos Exclusion Criteria: 1. a history of endocrine diseases. 2. a history of hysteroscopic surgeries. 3. cardiovascular, renal and liver diseases. 4. hypotension (blood pressure <90/50 mmHg). 5. a history of stroke or myocardial infarction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
+201005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Said, MSc
Phone
01013903948
Email
Medo_said14@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Vaginal Sildenafil Citrate on Endometrial Preparation and Outcome in Frozen Thawed Embryo Transfer Cycles

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