NCT02775734

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

May 16, 2016

Last Update Submit

April 28, 2017

Conditions

Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Keywords

Polycystic Ovary SyndromeN-acetyl-cysteineClomiphene citrateClomiphene citrate resistantLaparoscopic ovarian drillingtherapy

Outcome Measures

Primary Outcomes (1)

  • Biochemical pregnancy rate

    6 months

Secondary Outcomes (7)

  • Clinical pregnancy rate

    6 months

  • Live-birth rate

    15 months

  • Ovulation rate

    6 months

  • follicles more than or equal 18 mm

    6 months

  • Pre-ovulatory endometrial thickness

    6 months

  • +2 more secondary outcomes

Study Arms (2)

N-acetyl-cysteine

ACTIVE COMPARATOR

N-acetyl-cysteine + Clomiphene citrate + LOD

Drug: N-acetyl-cysteineDrug: Clomiphene citrate

NO N-acetyl-cysteine

ACTIVE COMPARATOR

Clomiphene citrate + LOD

Drug: Clomiphene citrate

Interventions

N-acetyl-cysteineDRUG

N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling

N-acetyl-cysteine
Clomiphene citrateDRUG

Clomiphene citrate + Laparoscopic ovarian drilling

N-acetyl-cysteineNO N-acetyl-cysteine

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

AcetylcysteineClomiphene

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 18, 2016

Study Start

May 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

EG(1)