Polycystic Ovary Syndrome Clinical Trial
Official title:
Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
NCT number | NCT04610957 |
Other study ID # | 5111 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | April 10, 2019 |
Verified date | October 2020 |
Source | Zagazig University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 160 |
Est. completion date | April 10, 2019 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine | Zagazig | Sharkia |
Lead Sponsor | Collaborator |
---|---|
FAlbasri |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy rate | defined as the presence of gestational sac containing fetal hearts on ultrasound scan | up to 24 weeks | |
Secondary | Endometrial thickness, | endometrial thickness is used to monitor infertility treatment | up to 24 weeks | |
Secondary | ovulation rate | Ovulation rate was taken as the gold standard for assessment of ovulation induction result | up to 24 weeks |
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