Ovulation Induction, Polycystic Ovary Syndrome
Conditions
Keywords
Human chorionic gonadotropin, clomiphene Citrate, Isoflavonoids, polycystic ovary syndrome
Brief summary
This prospective, randomized clinical trial double blinded study, has been carried on 160 infertile patients seeking pregnancy in Gynecology and Obstetrics Department, Zagazig University Hospitals during the period from January 2019 to November 2019, the participants' randomizations were done and patients divided into two groups; group I: included 80 women receiving Clomiphene citrate (CC) plus Isoflavonoids. Group 2: included 80 women receiving Clomiphene citrate only
Detailed description
Phytoestrogens continue to be of increasing interest because of their possible influence on the physiology of the reproductive tract. The aim of Prospective randomized clinical trial study is to evaluate effect of adding isoflavonoids to clomiphene citrate during ovulation induction in women with PCOS on the endometrial thickness which has an impact on pregnancy rate. This study included 160 infertile women seeking pregnancy and they were divided into two groups. Clomiphene is given orally at dose, one tablet twice per day (tablet 50 mg), from day 3 to day 7 for all patients (group I and group II),while phytoestrogens are given at dose, two tablets two times per day (tablet 800mg), from day 3 to day 12 only for group I, followed by HCG injection on attaining mature follicle(s) by trans-vaginal US scan with diameter ≥ 18 mm.
Interventions
DRUGRosafem (FEMININE FORMULA)
Rosafem is the only phytoestrogen product with the convenient dose which provides significant improvement of menopausal related symptoms premenstrual syndrome symptoms
Sponsors
FAlbasri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
• Patient aged 18- 35 years old with primary or secondary infertility
Exclusion criteria
* Patient aged 18- 35 years old with primary or secondary infertility * Patient whose husband has a male factor of infertility. * Hepatic, renal, diabetic, thyroid or cardiovascular disorders. * Organic pelvic disease (uterine fibroids or ovarian cysts). * Abnormality detected by HSG as blocked tubes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | up to 24 weeks | defined as the presence of gestational sac containing fetal hearts on ultrasound scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial thickness, | up to 24 weeks | endometrial thickness is used to monitor infertility treatment |
| ovulation rate | up to 24 weeks | Ovulation rate was taken as the gold standard for assessment of ovulation induction result |
Countries
Egypt
Outcome results
None listed