NCT00173758

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

December 21, 2005

Status Verified

June 1, 2005

First QC Date

September 13, 2005

Last Update Submit

December 20, 2005

Conditions

Keywords

IL-15IL-15 receptordecidual natural killer cellsendometrium

Outcome Measures

Primary Outcomes (3)

  • Fertilization rate of oocytes

  • Implantation rate of embryos

  • Pregnancy rate

Interventions

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Kuang-Han Chao, M.D.

    Department of Obstetrics and Gynecology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang-Han Chao, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Last Updated

December 21, 2005

Record last verified: 2005-06

Locations