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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT01008046

Collaborator

(none)

192

Enrollment

Location

Arms

Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: combined N-acetyl cysteine -CC Drug: combined metformin-CC	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: combined 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	Drug: combined 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
Active Comparator: combined 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.	Drug: combined 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

Arm

Intervention/Treatment

Experimental: combined 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

Drug: combined N-acetyl cysteine -CC

Active Comparator: combined 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.

Drug: combined metformin-CC

Outcome Measures

Primary Outcome Measures

Ovulation rate []

Secondary Outcome Measures

pregnancy rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 36 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

CC resistant PCOS

Exclusion Criteria:

Congenital adrenal hyperplasia
Cushing syndrome
Androgen secreting tumors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospitals,OB/GYN department	Mansoura	Dakahlia Governorate	Egypt

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Hatem Abu Hashim, MD. MRCOG, Mansoura University Hospital
Study Chair: Kamal Anwar, MD, Mansoura University Hospital
Study Director: Rafat Abd El-Fatah, MD, Mansoura University Hospital