Completed

Dr. Pao-Lin Kuo (Department of Obstetrics and Gynecology)

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
DNA Samples
Who is being recruted

Abortion, Spontaneous+4

+ Abortion, Habitual

+ Urogenital Diseases

From 25 to 45 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: August 2011
See protocol details

Summary

Principal SponsorNational Cheng-Kung University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleDr. Pao-Lin Kuo (Department of Obstetrics and Gynecology)
NCT04141618
Principal SponsorNational Cheng-Kung University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

143 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Abortion, SpontaneousAbortion, HabitualUrogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsInfertilityPregnancy Complications

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

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

Suspended

National Cheng-Kung University Hospital

Tainan, TaiwanOpen National Cheng-Kung University Hospital in Google Maps
CompletedOne Study Center