Sildenafil Effect After Ovulation Induction

Phase 4

• Conditions: Infertility
• Interventions: Drug: Clomiphene citrate; Drug: Placebo; Drug: sildenafil citrate

• Registration Number: NCT02890238
• Lead Sponsor: Cairo University

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)

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	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
sildenafil citrate	sildenafil citrate	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
placebo group	Clomiphene citrate	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
sildenafil citrate	Clomiphene citrate	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

Primary Outcome Measures

Name	Time	Method
Pregnancy rate per cycle	14 days after HCG triggering of ovulation	Serum pregnancy test

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt