Infertility, Female
Conditions
Brief summary
One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation.
Detailed description
One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end of menstruation through ovulation. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic pregnancy, and multiple pregnancies, were monitored.
Interventions
DRUGSildenafil Citrate
oral sildenafil (Respatio® 20mg )
used for ovionulation induct
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* ages of 18 to 40 * patent tubes * unexplained infertility * regular menstrual cycle * husband with normal sperm parameters
Exclusion criteria
* hypotension * cardiovascular, renal and hepatic diseases * uncontrolled diabetes mellitus * anovulatory infertility * abnormal thyroid functions * ovarian cysts * patients taking nitrates * pelvic adhesions * abnormal hormonal profile. * hyperprolactinemia * multiple uterine fibroids * adenomyosis and endometriosis suspicion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | at the end of the cycle (28 days) | Serum pregnancy test (positive/negative) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| endometrial thickness | 1 month | measured by trans-vaginal ultrasound |
| ovulation rate | 1 month | using trans-vaginal ultrasound |
Countries
Egypt
Outcome results
None listed