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Sildenafil Effect After Ovulation Induction

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Clomiphene citrate
sildenafil citrate
Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Sildenafil Citrate, Induction of Ovulation, Pregnancy Rate

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Infertile women whether it's primary or secondary infertility
  2. Woman's age: (18-35 years old)
  3. Menstrual cycle from (24-35 days)
  4. Normal semen analysis

Exclusion Criteria:

  1. Age more than 35 years old
  2. Ovarian cysts
  3. Abnormal hormonal profile (e.g hyperprolactinaemia)
  4. Significant cardiovascular disease
  5. Serious liver disease or renal failure
  6. Poorly controlled diabetes mellitus

Sites / Locations

  • Kasr Alainy medical schoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

sildenafil citrate

placebo group

Arm Description

50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd - 7th day of the cycle and sildenafil citrate 20mg tab from 7th-11th day of the same cycle orally 3times/day

50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd- 7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day

Outcomes

Primary Outcome Measures

Pregnancy rate per cycle
Serum pregnancy test

Secondary Outcome Measures

Full Information

First Posted
August 29, 2016
Last Updated
September 20, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02890238
Brief Title
Sildenafil Effect After Ovulation Induction
Official Title
Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
100 women with infertility classified into 2 groups. Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day. Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.
Detailed Description
100 women with infertility classified into 2 groups. Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day. Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day. Folliculometry was assessed by: Transvaginal ultrasound: It was done on day 11th of the cycle to detect number of follicles and endometrial thickness. When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation to both groups. Pregnancy was assessed by: Beta HCG test: (Radioimmunoassay)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Sildenafil Citrate, Induction of Ovulation, Pregnancy Rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sildenafil citrate
Arm Type
Active Comparator
Arm Description
50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd - 7th day of the cycle and sildenafil citrate 20mg tab from 7th-11th day of the same cycle orally 3times/day
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd- 7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day
Intervention Type
Drug
Intervention Name(s)
Clomiphene citrate
Other Intervention Name(s)
clomid
Intervention Description
50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate
Other Intervention Name(s)
Viagra
Intervention Description
20mg tab from 7th-11th day of the same cycle orally 3times/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tab from 7th-11th day of the same cycle orally 3times/day
Primary Outcome Measure Information:
Title
Pregnancy rate per cycle
Description
Serum pregnancy test
Time Frame
14 days after HCG triggering of ovulation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infertile women whether it's primary or secondary infertility Woman's age: (18-35 years old) Menstrual cycle from (24-35 days) Normal semen analysis Exclusion Criteria: Age more than 35 years old Ovarian cysts Abnormal hormonal profile (e.g hyperprolactinaemia) Significant cardiovascular disease Serious liver disease or renal failure Poorly controlled diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Sildenafil Effect After Ovulation Induction

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