NCT02344888

Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS

Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Mahmoud Thabet · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).

Detailed description

Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the 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 human chorionic gonadotropin (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 mid-luteal 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

Conditions

• Infertility
• Polycystic Ovarian Syndrome

Interventions

Type	Name	Description
DRUG	Clomiphene citrate and Prednisolone	Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of the cycle)
DRUG	Clomiphene citrate and folic acid	Women will receive clomiphene citrate alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid (0.5 mg/day for 10 consecutive days from day 2 of the cycle)

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2015-01-26
• Last updated: 2019-01-08

Locations

2 sites across 1 country: Egypt