Incidence of Early Pregnancy Loss in Patients With Unexplained Infertility (UNEXPLAINED)
This study has been completed.
Sponsor:
UMC Utrecht
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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 (Adult) |
| 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
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
| 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, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on September 26, 2016