NAC in CC Resistant PCOS After LOD (NAC)

April 28, 2017 updated by: Mohamed S Sweed, MD, Ain Shams University

N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial

This prospective randomized placebo-controlled double blind clinical trial will conducted in Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200 mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation, mid- luteal sub-endometrial blood flow indices, and incidence of side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Body mass index (BMI) between 25 and 30 Kg/m 2.
  • CC-resistant Polycystic ovary syndrome

Exclusion Criteria:

  • • Patients with BMI under 25 or over 30 Kg/m 2.

    • Hyper or hypothyroidism, or hyperprolactinemia.
    • Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs.
    • Intention to start a diet or a specific program of physical activity.
    • Organic pelvic diseases.
    • Tubal or male factor infertility.
    • Interval of earlier treatment with any of the fertility drugs of less than 6 months.

    • Contraindication to either:

      • Clomiphene citrate: liver disease, undiagnosed abnormal uterine bleeding, uterine fibroids, endometrial cancer, ovarian enlargement or hyper stimulation
      • HCG injection: ovarian enlargement or hyper stimulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: N-acetyl-cysteine
N-acetyl-cysteine + Clomiphene citrate + LOD
Drug: N-acetyl-cysteine
N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling
Drug: Clomiphene citrate
Clomiphene citrate + Laparoscopic ovarian drilling
ACTIVE_COMPARATOR: NO N-acetyl-cysteine
Clomiphene citrate + LOD
Drug: Clomiphene citrate
Clomiphene citrate + Laparoscopic ovarian drilling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biochemical pregnancy rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 6 months
6 months
Live-birth rate
Time Frame: 15 months
15 months
Ovulation rate
Time Frame: 6 months
6 months
follicles more than or equal 18 mm
Time Frame: 6 months
6 months
Pre-ovulatory endometrial thickness
Time Frame: 6 months
6 months
mid-luteal sub-endometrial doppler blood flow indices
Time Frame: 6 months
6 months
Incidence of side effects
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (ESTIMATE)

May 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS1275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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