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

November 17, 2009 updated by: UMC Utrecht

Incidence of Early Pregnancy Loss in Patients With Unexplained Infertility Measured by hCG Rise in Urine

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

Inclusion Criteria:

  • Unexplained infertility

Exclusion Criteria:

  • IVF treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of early pregnancy loss
Time Frame: 3 mentrual cycles
3 mentrual cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of pregnancies
Time Frame: 3 menstual cycles
3 menstual cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: NS Macklon, Prof, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2009

Last Update Submitted That Met QC Criteria

November 17, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNEXPLAINED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe