NCT00700492

Brief Summary

A randomized study to investigate if hormonal luteal support after intra-uterine insemination (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the pregnancy rate

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

3.8 years

First QC Date

June 17, 2008

Last Update Submit

June 24, 2015

Conditions

Subfertility

Keywords

subfertilitypregnancy ratemiscarriage

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate per cycle

    12 weeks pregnancy

Secondary Outcomes (1)

  • rate of miscarriages per cycle

    12 weeks pregnancy

Study Arms (2)

control

NO INTERVENTION

utrogestan

EXPERIMENTAL

daily use of vaginal progesterone capsules

Drug: progesterone

Interventions

progesteroneDRUG

vaginal capsules 3X200mg daily

Also known as: Utrogestan
utrogestan

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent
  • Tubal patency demonstrated
  • ovulation induction with human menopausal gonadotropin

You may not qualify if:

  • ovulation induction with clomiphene citrate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leuven University Fertility Center

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

InfertilityAbortion, Spontaneous

Interventions

ProgesteroneUtrogestan

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Thomad D'Hooghe, MD, PhD

    University Hospital Gasthuisberg, Catholic University Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof PhD MD

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 18, 2008

Study Start

May 1, 2004

Primary Completion

March 1, 2008

Study Completion

June 1, 2008

Last Updated

June 25, 2015

Record last verified: 2015-06

Locations

BE(1)