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

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01015690
First received: November 17, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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
Infertility

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • incidence of early pregnancy loss [ Time Frame: 3 mentrual cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of pregnancies [ Time Frame: 3 menstual cycles ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

urine
Enrollment: 134
Study Start Date: June 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015690

Locations
Netherlands
UMCUtrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: NS Macklon, Prof UMC Utrecht
  More Information

No publications provided

Responsible Party: NS Macklon, Prof, PhD, UMCUtrecht
ClinicalTrials.gov Identifier: NCT01015690     History of Changes
Other Study ID Numbers: UNEXPLAINED
Study First Received: November 17, 2009
Last Updated: November 17, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on February 26, 2015