Dr. Pao-Lin Kuo (Department of Obstetrics and Gynecology)
Data Collection
Collected at a single point in time - Cross-sectionalAbortion, Spontaneous+4
+ Abortion, Habitual
+ Urogenital Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: August 1, 2011
Actual date on which the first participant was enrolled.This study focuses on Recurrent Miscarriage (RM) and Hydatidiform Mole (HM), conditions that affect 1% to 5% of couples and 1 in every 1500 pregnancies in the West, respectively. RM is defined as two or more consecutive miscarriages before the 20th week of pregnancy, while HM is a rare mass or growth that forms inside the uterus at the beginning of a pregnancy. The exact causes of RM and HM are unknown in most cases. However, research suggests that the NLRP family of genes, particularly NLRP7, may play a significant role. These genes are known for their roles in apoptosis (cell death) and inflammation, and they express differently in human eggs and early embryonic cells. Mutations in NLRP7 have been found in women experiencing repeated molar pregnancies, stillbirths, or early miscarriages, suggesting it as a strong candidate gene for RM/HM. This study aims to understand these genetic links better, potentially improving care and addressing the challenges faced by affected couples. The study is observational, meaning participants will not receive any specific treatment. Instead, the researchers will observe and record the outcomes of pregnancies. The primary outcome measured is the delivery of a normal baby, which is considered a normal pregnancy outcome. This study does not mention any potential risks, but it aims to provide valuable insights into the role of NLRP7 in RM and HM, which could lead to improved understanding and care for these conditions.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.143 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 25 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Recurrent abortions and infertility treatments but combined with repetitive (more than two consecutive) implantation failure couples, rather than general infertility couples. Exclusion Criteria: Women who do not have recurrent miscarriage and infertility problems.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Cheng-Kung University Hospital
Tainan, TaiwanOpen National Cheng-Kung University Hospital in Google Maps