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

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


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:

Further study details as provided by UMC Utrecht:

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

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

Biospecimen Retention:   Samples Without DNA

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)
unexplained infertility
patients with unexplained infertility
healthy controls
women who wish to conceive, no more tha 3 previous cycles, age above 18
lesbian women with a regular cycle without use of anticonception and not at risk of becoming pregnant


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

Inclusion Criteria:

  • Unexplained infertility

Exclusion Criteria:

  • IVF treatment
  Contacts and Locations
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Please refer to this study by its identifier: NCT01015690

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

Responsible Party: NS Macklon, Prof, PhD, UMCUtrecht Identifier: NCT01015690     History of Changes
Other Study ID Numbers: UNEXPLAINED
Study First Received: November 17, 2009
Last Updated: November 17, 2009

Keywords provided by UMC Utrecht:
unexplained infertility
early pregnancy loss

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on August 18, 2017