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Sildenafil Effect After Ovulation Induction

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Unknown
Phase 4

Conditions

Infertility

Treatments

Drug: sildenafil citrate
Drug: Placebo
Drug: Clomiphene citrate

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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)

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups, including a placebo group

sildenafil citrate
Active Comparator group
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
Treatment:
Drug: Clomiphene citrate
Drug: sildenafil citrate
placebo group
Placebo Comparator group
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
Treatment:
Drug: Placebo
Drug: Clomiphene citrate

Trial contacts and locations

1

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Central trial contact

Ahmed Maged

Data sourced from clinicaltrials.gov

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