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

Condition(s) targeted: Infertility; Polycystic Ovarian Syndrome

Intervention: Clomiphene citrate and Prednisolone (Drug); Clomiphene citrate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Mohamed Sayed Abdelhafez

Official(s) and/or principal investigator(s):
Mahmoud M Abdel-razik, Dr, Principal Investigator, Affiliation: Mansoura University
Mohamed S Abdelhafez, Dr, Study Director, Affiliation: Mansoura University
Ahmed M Badawy, Prof, Study Chair, Affiliation: Mansoura University

Overall contact:
Mahmoud M Abdel-razik, Dr, Phone: +201005548881, Email: dr_mahmoudhosam@yahoo.com

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).

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Ovulation rate

Secondary outcome:

Number of ovarian follicles ≥ 18 mm on day of HCG administration

Endometrial thickness on day of HCG administration

Clinical pregnancy rate

Detailed description: Women will be randomly divided into two groups; CC-Prednisolone group and CC group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 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 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 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

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

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

Mahmoud M Abdel-razik, Dr, Phone: +201005548881, Email: dr_mahmoudhosam@yahoo.com

Obstetrics and Gynecology Department in Mansoura University Hospital, Mansoura, Dakahlia 35111, Egypt; Recruiting
Mahmoud M Abdel-razik, Dr, Phone: +201005548881, Email: dr_mahmoudhosam@yahoo.com

Private practice settings, Mansoura, Dakahlia, Egypt; Recruiting

Starting date: February 2015
Last updated: July 20, 2015