Subfertility, Female
Conditions
Brief summary
. This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.
Detailed description
The study is a randomized controlled trial that was carried on 148 infertile women with unexplained infertility. Patients were divided into 3 groups. Group 1 included 48 patients who received oral estradiol valerate (Cyclo-Progynova 2mg, from day 8th till triggering of ovulation), another 50 patients in group 2 received oral Sildenafil (Respatio 20mg/12hr film coated tablets for 5 days starting from last day of menstruation till ovulation), while group 3 was the control one who included 50 patients were given ovulation induction with CC 50mg/12hr from 2nd to 7th day of cycle. Every patient underwent a transvaginal ultrasound to determine ovulation, number of follicles, and pregnancy rates. Miscarriage, ectopic pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse consequences.
Interventions
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* aged between 18 to 40 years * unexplained infertility (primary or secondary) * had a regular menstrual cycle; * patent tubes; * husbands with normal semen parameters.
Exclusion criteria
* hypotension; * cardiovascular, hepatic, and renal diseases; * uncontrolled diabetes mellitus; * anovulatory infertility; * ovarian cysts; * pelvic adhesions; * hyperprolactinemia; * abnormal thyroid functions; * multiple uterine fibroids; * patients on nitrates; * suspicion of endometriosis and adenomyosis, * subjects have known to receive any treatment for fertility in the last six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy rates | at the end of each of 3 cycles (28 days) | measure B HCG and detect number of cases get pregnant in each cycle 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ovulation | 3 months | measuring dominant follicle starting from D9 of the cycle till reaching 18-20mm |
Countries
Egypt
Outcome results
None listed