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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02344888
• Other study ID #: MMA1
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: January 2019

Study information

• Verified date: January 2019
• Source: Mansoura University
• Contact: Mahmoud M Abdelrazik, Dr
• Phone: +201005548881
• Email: dr_mahmoudhosam[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

• Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m2.

• 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

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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)
• 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)

Locations

Country	Name	City	State
Egypt	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansourah	Dakahlia
Egypt	Private practice settings	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mahmoud Thabet

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation rate	Number of ovulatory cycles divided by the number of stimulation cycles	3 months
Secondary	Number of ovarian follicles = 18 mm on day of HCG administration	Number of ovarian follicles = 18 mm by TVS on day of HCG administration	3 months
Secondary	Endometrial thickness on day of HCG administration	Endometrial thickness by TVS on day of HCG administration	3 months
Secondary	Clinical pregnancy rate	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	6-8 weeks gestational age