Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS

Mohamed Sayed Abdelhafez

Status and phase: Completed; Phase 4

Conditions: Infertility; Polycystic Ovarian Syndrome

Treatments: Drug: Clomiphene citrate and Human chorionic gonadotropin (HCG); Drug: Clomiphene citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02436226

MT1

Details and patient eligibility

About

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).

Full description

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

Enrollment: 300 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.
• 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-HCG group

Active Comparator group

Description:

Women will receive clomiphene citrate and human chorionic gonadotropin (HCG)

Treatment:

Drug: Clomiphene citrate and Human chorionic gonadotropin (HCG)

Clomiphene citrate group

Active Comparator group

Description:

Women will receive clomiphene citrate alone

Treatment:

Drug: Clomiphene citrate