N-acetyl Cysteine for Ovulation Induction in Clomiphene Citrate Resistant Polycystic Ovary Syndrome

NCT02239107 | Completed Phase 4 DMC

• 1 other identifier: n-acetyl cysteine PCOS
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction. Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy, some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and pregnancy rate.

Conditions

Polycystic Ovary Syndrome

Keywords

polycystic ovary syndrome; laparoscopic drilling; clomiphene citrate; n acetyl cysteine; insulin resistance

Outcome Measures

Primary Outcomes (1)

• ovulation rate

  ovulation will be assessed by serial transvaginal ultrasound monitoring when feasible or day 21 serum progesterone

  6 month

Secondary Outcomes (1)

• pregnancy rate

  2 years

Study Arms (2)

N-Acetyl cysteine

EXPERIMENTAL

Laparoscopic ovarian drilling followed by NAC 1200mg daily in two divided doses for five days starting cycle day 2 for 6 month

Drug: N-Acetyl cysteine; Procedure: laparoscopic ovarian drilling

laparoscopic drilling group

ACTIVE COMPARATOR

laparoscopic drilling only will be done

Procedure: laparoscopic ovarian drilling

Interventions

N-Acetyl cysteine DRUG

Also known as: Acetyl cysteine, NAC

N-Acetyl cysteine

laparoscopic ovarian drilling PROCEDURE

N-Acetyl cysteine; laparoscopic drilling group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PCOS patients according to Rotterdam criteria who failed to respond to 6 month ovulation induction therapy with clomiphene citrate,
• normal semen analysis of partner
• normal tubo-peritoneal anatomy as assessed by laparoscopy

You may not qualify if:

• patients who have other causes of infertility
• patients receiving gonadotrophin ovulation induction

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Esraa yousef Badran

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 12, 2014
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: September 12, 2014

Record last verified: 2014-09