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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 November 2023 |
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Main ID: |
NCT02436226 |
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Date of registration:
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02/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS
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Scientific title:
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Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02436226 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Mahmoud M Abdel-razik, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Khaled S Ismael, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Maged R Elshamy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Ahmed Ragab, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Hamed Youssef, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Mohamed A Elnegery, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Mahmoud Thabet, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Mohamed S Abdelhafez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infertile lean women with PCOS as defined by the Rotterdam criteria.
- CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5
consecutive days per cycle, for at least 3 consecutive cycles).
Exclusion Criteria:
- Age < 20 or > 35 years.
- Presence of any infertility factor other than anovulatory PCOS.
- Previous history of ovarian surgery or surgical removal of one ovary.
- Previous exposure to cytotoxic drugs or pelvic irradiation.
- Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
- Metabolic or hormonal abnormalities.
Age minimum:
20 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Polycystic Ovarian Syndrome
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Infertility
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Intervention(s)
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Drug: Clomiphene citrate and Human chorionic gonadotropin (HCG)
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Drug: Clomiphene citrate
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Primary Outcome(s)
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Ovulation rate
[Time Frame: 3 months]
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Secondary Outcome(s)
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Clinical pregnancy rate
[Time Frame: 6-8 weeks gestational age]
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Number of ovarian follicles = 18 mm on day of triggering of oocyte maturation
[Time Frame: 3 months]
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Endometrial thickness on day of triggering of oocyte maturation
[Time Frame: 3 months]
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Incidence of early ovarian hyperstimulation syndrome (OHSS)
[Time Frame: Within 9 days of final triggering of oocyte maturation]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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