Sildenafil Effect After Ovulation Induction

Infertility Clinical Trial

Official title:

Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02890238
• Other study ID #: 156
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: Ahmed Maged
• Phone: 01005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Clomiphene citrate
50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle
• sildenafil citrate
20mg tab from 7th-11th day of the same cycle orally 3times/day
• Placebo
tab from 7th-11th day of the same cycle orally 3times/day

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate per cycle	Serum pregnancy test	14 days after HCG triggering of ovulation