Sildenafil Effect After Ovulation Induction

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

NCT02890238

156

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