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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01015690

First Posted: November 18, 2009

Last Update Posted: November 18, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

UMC Utrecht

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:

MedlinePlus related topics: Infertility

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 ]

Secondary Outcome Measures:

incidence of pregnancies [ Time Frame: 3 menstual cycles ]

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

Information from the National Library of Medicine

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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

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


Responsible Party:	NS Macklon, Prof, PhD, UMCUtrecht
ClinicalTrials.gov Identifier:	NCT01015690 History of Changes
Other Study ID Numbers:	UNEXPLAINED
First Submitted:	November 17, 2009
First Posted:	November 18, 2009
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 Genital Diseases, Male Genital Diseases, Female

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