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

Mahmoud Thabet

Status and phase: Unknown; Phase 4

Conditions: Infertility; Polycystic Ovarian Syndrome

Treatments: Drug: Clomiphene citrate and folic acid; Drug: Clomiphene citrate and Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02344888

MMA1

Details and patient eligibility

About

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).

Full 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

Enrollment: 300 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Clomiphene citrate-Prednisolone group

Active Comparator group

Description:

Women will receive clomiphene citrate and prednisolone

Treatment:

Drug: Clomiphene citrate and Prednisolone

Clomiphene citrate-placebo group

Active Comparator group

Description:

Women will receive clomiphene citrate and folic acid 0.5mg (placebo)

Treatment:

Drug: Clomiphene citrate and folic acid