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The Expression of IL-15 and Its Receptor in Decidua

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00173758
First Posted: September 15, 2005
Last Update Posted: December 21, 2005
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:
National Taiwan University Hospital
  Purpose

Human decidual tissue appears to play an important role not only in nurturing the implanted embryos, but also in preventing its rejection by the maternal immune system. Insight into the maternal immunologic modulations during implantation is our main research interests. Our previous studies have shown that most lymphocytes in deciduae are natural killer cells. However, their phenotype is CD16-CD56+CD3-, which is different from that of peripheral natural killer cells. More importantly their cytotoxic activity is decreased and they can’t attack the cytotrophoblasts. All of these contributes to no rejection developing at the fetomaternal interface and are related to success of pregnancy.

In 1994, a new cytokine IL-15 was first discovered, which could act on the IL-15 and IL-2 receptors to stimulate the activation and propagation of the lymphocytes. Let us want to study the critical role of IL-15 in the endometrial lymphocytes. In this study, we try to analyze the distribution of IL-15 and its receptor in deciduae. We will clarify whether the IL-15 receptor exists on the decidual natural killer cells and it is regulated by sexual hormones or not and whether their cytotoxic activity will change after IL-15 action. Furthermore, we will demonstrated whether the IL-15 receptor exists on the embryo cells and IL-15 might improve the quality of the embryo. We also design a co-culture system of the embryo and autologous endometrial cells to improve the success rate of in vitro fertilization.


Condition Intervention
Pregnancy Infertility Procedure: co-culture of embryos and endometrial cells

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Expression of IL-15 and Its Receptor in Uterine NK Cells and Clinical Applications

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Fertilization rate of oocytes
  • Implantation rate of embryos
  • Pregnancy rate

Estimated Enrollment: 30
Study Start Date: September 2005
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages between 20 and 40 years
  • Written informed consent
  • Regular cycles, between 21 and 35 days, within the last 6 months before pregnancy
  • Early pregnancy between 4 to 10 weeks of gestation

Exclusion Criteria:

  • Abnormal vaginal bleeding
  • Concomitant treatment with other drugs
  • Autoimmune diseases
  • Pelvic inflammation with last 3 months
  • Having any associated malignancy
  • Unable or unwilling to comply fully with the protocol
  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): NCT00173758


Contacts
Contact: Kuang-Han Chao, M.D. 886-2-2312-3456 ext 5539 khchao@ntumc.org

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Kuang-Han Chao, M.D.    886-2-2312-3456 ext 5539    khchao@ntumc.org   
Principal Investigator: Kuang-Han Chao, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Kuang-Han Chao, M.D. Department of Obstetrics and Gynecology, National Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00173758     History of Changes
Other Study ID Numbers: 9361701276
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: December 21, 2005
Last Verified: June 2005

Keywords provided by National Taiwan University Hospital:
IL-15
IL-15 receptor
decidual natural killer cells
endometrium

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