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

N-acetyl Cysteine Plus Clomiphene Citrate Versus Metformin and Clomiphene Citrate in Treatment of Clomiphene-resistant Polycystic Ovary Syndrome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01008046

Enrollment

192

Registered

2009-11-05

Start date

2007-04-30

Completion date

2009-06-30

Last updated

2009-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome, clomiphene resistance, metformin, N-acetyl cysteine

Brief summary

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.

Detailed 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.

Interventions

DRUGcombined N-acetyl cysteine -CC

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

DRUGcombined metformin-CC

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 36 Years

Healthy volunteers

Inclusion criteria

* CC resistant PCOS

Exclusion criteria

* Congenital adrenal hyperplasia * Cushing syndrome * Androgen secreting tumors

Design outcomes

Primary

Measure	Time frame
Ovulation rate	—

Secondary

Measure	Time frame
pregnancy rate	—

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026