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Incidence of Early Pregnancy Loss in Patients With Unexplained Infertility (UNEXPLAINED)

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ClinicalTrials.gov Identifier: NCT01015690
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : November 18, 2009
Sponsor:
Information provided by:
UMC Utrecht

Study Description
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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.

Condition or disease
Infertility

Study Design
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Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Incidence of Early Pregnancy Loss in Patients With Unexplained Infertility Measured by hCG Rise in Urine
Study Start Date : June 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. incidence of early pregnancy loss [ Time Frame: 3 mentrual cycles ]

Secondary Outcome Measures :
  1. incidence of pregnancies [ Time Frame: 3 menstual cycles ]

Biospecimen Retention:   Samples Without DNA
urine

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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
Criteria

Inclusion Criteria:

  • Unexplained infertility

Exclusion Criteria:

  • IVF treatment
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015690


Locations
Netherlands
UMCUtrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: NS Macklon, Prof UMC Utrecht
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: NS Macklon, Prof, PhD, UMCUtrecht
ClinicalTrials.gov Identifier: NCT01015690     History of Changes
Other Study ID Numbers: UNEXPLAINED
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: November 18, 2009
Last Verified: November 2009

Keywords provided by UMC Utrecht:
unexplained infertility
hCG
early pregnancy loss

Additional relevant MeSH terms:
Infertility
Abortion, Spontaneous
Genital Diseases, Male
Genital Diseases, Female
Pregnancy Complications