NCT01015690

Brief Summary

Unexplained fertility could be partly caused by a higher incidence of early pregnancy loss in this group. 65 women with unexplained infertility and 65 healthy controls will collect daily urine samples form the luteal phase. hCG and creatinine levels are measured in order to detect pregnancies and early pregnancy loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Typical duration for all trials

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

June 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
Last Updated

November 18, 2009

Status Verified

November 1, 2009

Enrollment Period

2.8 years

First QC Date

November 17, 2009

Last Update Submit

November 17, 2009

Conditions

Infertility

Keywords

unexplained infertilityhCGearly pregnancy loss

Outcome Measures

Primary Outcomes (1)

  • incidence of early pregnancy loss

    3 mentrual cycles

Secondary Outcomes (1)

  • incidence of pregnancies

    3 menstual cycles

Study Arms (3)

unexplained infertility

patients with unexplained infertility

healthy controls

women who wish to conceive, no more tha 3 previous cycles, age above 18

references

lesbian women with a regular cycle without use of anticonception and not at risk of becoming pregnant

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with unexplained infertility and healthy controls have collected urine samples in the luteal phase of the menstrual cycle for detection of hCG rise and pregnancy

You may qualify if:

  • Unexplained infertility

You may not qualify if:

  • IVF treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMCUtrecht

Utrecht, Utrecht, 3508 GA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Conditions

InfertilityAbortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • NS Macklon, Prof

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

June 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 18, 2009

Record last verified: 2009-11

Locations

NL(1)