Spots Global Cancer Trial Database for Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS
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Trial Identification
Brief Title: Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS
Official Title: Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
Study ID: NCT02436226
Study Description
Brief Summary: The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).
Detailed Description: Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of HCG and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Obstetrics and Gynecology Department in Mansoura University Hospital, Mansourah, , Egypt
Contact Details
Name: Mahmoud Thabet, MD
Affiliation: Mansoura University
Role: PRINCIPAL_INVESTIGATOR
Name: Khaled S Ismael, MD
Affiliation: Mansoura University
Role: STUDY_DIRECTOR
Name: Ahmed Ragab, MD
Affiliation: Mansoura University
Role: STUDY_DIRECTOR
Name: Maged R Elshamy, MD
Affiliation: Mansoura University
Role: STUDY_DIRECTOR
Name: Mohamed A Elnegery, MD
Affiliation: Mansoura University
Role: STUDY_DIRECTOR
Name: Hamed Youssef, MD
Affiliation: Mansoura University
Role: STUDY_DIRECTOR
Name: Mahmoud M Abdel-razik, MD
Affiliation: Mansoura University
Role: STUDY_DIRECTOR
Name: Mohamed S Abdelhafez, MD
Affiliation: Mansoura University
Role: STUDY_CHAIR
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