NCT01638988

Brief Summary

The results of studies conducted until now does not determine what the best way to treat infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study objective is to determine the best treatment for such patients. The long-term consequence health of women with PCOS are multiple. The woman with PCOS has a risk of developing metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin resistance plays an important role in all this medical condition. Clomiphene Citrate (CC) remains the first line treatment to induce ovulation in women with PCOS and anovulatory infertility.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

July 9, 2012

Last Update Submit

July 24, 2015

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Biochemical pregnancy

    Rate of biochemical pregnancy

    1 month

Secondary Outcomes (6)

  • Ovulation rate

    1 month

  • Live birth rate

    6 months

  • Spontaneous abortion rate

    6 months

  • BMI and waist size changing

    6 months

  • Insulin resistance changing

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Metformin

EXPERIMENTAL
Drug: Metformin

Clomiphene Citrate

ACTIVE COMPARATOR
Drug: Clomiphene citrate

Interventions

MetforminDRUG

1. cycle 2000 mg of Metformin : Day 1 to day 30; beginning with 1/2 tablet by day with an increasing until 4 pills by day 2. to 6 cycle 2000 mg of Metformin : Day 1 ot day 30; 4 pills of Metformin by day Positive pregnancy test : 4 pills of Metformin by day until 12 weeks of pregnancy

Metformin
Clomiphene citrateDRUG

Cycle 1: Day 3 to day 7; 50 mg; 1 tablet of Clomiphene Citrate by day Cycle 2: Day 3 to day 7; 100 mg; 1 tablet of Clomiphene Citrate two times a day Cycle 3 to 6 : Day 3 to day 7; 150 mg; 1 tablet of Clomiphene Citrate 3 times a day

Clomiphene Citrate

Eligibility Criteria

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

You may qualify if:

  • Women aged from 18 to 35
  • Infertility for a period of a year or more or 6 month of irregular menstrual cycle
  • PCOS under the Rotterdam criteria
  • Insulin resistance HOMA-IR \> 2.5
  • Normal semen analysis values
  • Normal values of the following blood analysis: FSH, LH, Estradiol, AMH, TSH, Prolactine, Fasting glucose level, hemoglobin A1C, AST, ALT, alkaline phosphatase, SHBG, 17OH progesterone, DHEAS, Androstenedione, total testosterone, LDL, HDL, total cholesterol, Triglycerides, oral glucose tolerance test

You may not qualify if:

  • Tubular factor
  • Normal ovarian reserve
  • Prior use of CC or Metformin, hypoglycemic agents, glucocorticoids, anti-androgen, weight-loss agent or oral contraceptives in the past 6 months
  • Neoplasia
  • BMI \> 35
  • Renal, hepatic or cardiac failure
  • Lactic, acidosis antecedent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Interventions

MetforminClomiphene

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Jacques Kadoch, Dr

    Clinique Ovo

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 12, 2012

Study Start

September 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

CA(1)