Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, 35111, Egypt
NCT Number: NCT02436226
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).
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Notify Me20 year–35 year
Female
Interventional
Phase 4
Al Mansurah, 35111, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle)
Other names: Clomid and Choriomon
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)
Other names: Clomid
Time frame: 3 months
Number of ovulatory cycles divided by the number of stimulation cycles
Time frame: 3 months
Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation
Time frame: 3 months
Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation
Time frame: 6-8 weeks gestational age
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women
Time frame: Within 9 days of final triggering of oocyte maturation
Incidence of OHSS within 9 days of final triggering of oocyte maturation
Mohamed Sayed Abdelhafez
Other
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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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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