NCT00835744

Brief Summary

The purpose of the present study is to analyse prospectively if highly purified hMG compared with increased dose of clomiphene citrate has different outcomes in folliculogenesis in ovulation induction cycles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

3.6 years

First QC Date

February 3, 2009

Last Update Submit

March 27, 2012

Conditions

Infertility

Keywords

ovulation inductionclomiphene citrategonadotropins

Outcome Measures

Primary Outcomes (1)

  • folliculogenesis

    april 2009

Secondary Outcomes (1)

  • pregnancy rate

    april 2009

Study Arms (2)

A

PLACEBO COMPARATOR

Patients undergo a standard treatment with clomiphene citrate from day 3 until day 7 of the cycle at a dose of 50 mg daily. If no reaction on day 13 of the cycle, an increased dose of 100 mg of clomiphene citrate is administered from day 13 until day 17 of the cycle.

Drug: clomiphene citrate

B

ACTIVE COMPARATOR

Patients undergo a standard treatment with clomiphene citrate from day 3 until day 7 of the cycle at a dose of 50 mg daily. If no reaction on day 13 of the cycle, gonadotropins (75IU) are administered from day 13 until day 17 of the cycle.

Drug: gonadotropins

Interventions

clomiphene citrateDRUG

ovulation induction

A
gonadotropinsDRUG

ovulation induction

B

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \< 39 years old on day of randomisation
  • FSH \< 12 (in the early follicular phase)
  • Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
  • Chronic oligo or anovulation (WHO 2)
  • BMI between 18 and 31 (both inclusive)

You may not qualify if:

  • ≥ 39 years old on day of randomisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Infertility

Interventions

ClomipheneGonadotropins

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

August 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

BE(1)