N-acetyl Cysteine and Clomiphene Citrate or Metformin and Clomiphene Citrate for Women With CC Resistant Polycystic Ovary Syndrome (PCOS).

Mansoura University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: combined N-acetyl cysteine -CC; Drug: combined metformin-CC

Study type: Interventional

Funder types: Other

Identifiers

NCT01008046

FMH-112-M

MU- 183

Details and patient eligibility

About

The purpose of this study is to compare and determine the efficacy of combined N-acetyl cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.

Full description

In combined NAC-CC group group,patients received NAC (200 mg per sachet, SEDICO, Egypt) for 5-6 weeks from the 1st day of of spontaneous or induced menstruation (in a dose of 1.8 g orally in three divided doses, 3 sachets per dose). All patients in other group received metformin HCl (Cidophage®; Chemical Industries Development, Egypt), 500 mg thrice daily for 5-6 weeks from the 1st day of spontaneous or induced menstruation. Then after the end of this period, patients in either group received 100 mg CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation, it was increased by 50 mg for the next cycle. Patients continued treatment for three successive cycles using the same protocol. NAC and metformin were stopped only when pregnancy was documented.

Enrollment: 192 patients

Sex: Female

Ages: 20 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CC resistant PCOS

Exclusion criteria

• Congenital adrenal hyperplasia
• Cushing syndrome
• Androgen secreting tumors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

combined N-acetyl cysteine - CC

Experimental group

Description:

N-acetyl cysteine(1.8 g orally daily)for 5-6 weeks from the 1st day of spontaneous or induced menstruation followed by 100 mg CC for 5 days from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles

Treatment:

Drug: combined N-acetyl cysteine -CC

combined metformin-CC

Active Comparator group

Description:

Patients received metformin HCl (1500 mg daily) for 5-6 weeks from the 1st day of spontaneous or induced menstruation, followed by 100 mg CC for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles.

Treatment:

Drug: combined metformin-CC