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Trial registered on ANZCTR

Registration number

ACTRN12613000221752

Ethics application status

Approved

Date submitted

28/01/2013

Date registered

25/02/2013

Date last updated

25/02/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

Establishing an open access Biobank of human Fallopian tubes

Scientific title

Open Access Biobank of Human Fallopian Tubes: A prospective biomedical study of archived tissue samples to elucidate mechanisms of abnormal implantation including a molecular make-up of early maternal-embryonic interface, trophoblast proliferation and its paracrine/autocrine regulation in tubal ectopic pregnancy.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1138-7484

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Infertility

Tubal ectopic pregnancy

Pathogenesis of abnormal implantation

Carcinogenesis

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Reproductive Health and Childbirth

Fertility including in vitro fertilisation

Cancer

Ovarian and primary peritoneal

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The project is a prospective biomedical study of archived specimens of Fallopian tube tissue and peripheral venous blood obtained from consented women age group from 21 to 50 years old who had salpingectomy for tubal ectopic pregnancy. A comparison group will include intact Fallopian tubes and peripheral blood samples from consented women of the same age group who underwent hysterectomy for non-malignant disease or tubal ligation for permanent contraception. All biological samples will be coupled to a detailed, anonymised medical history of each participant.

This project aims to address the lack of human samples for research in the areas of embryonic implantation and implantation failure, pathogenesis of ectopic pregnancy and understanding of malignant tissue invasion using trophoblast as a model system by establishing a collection of Fallopian tubes samples from patients undergoing surgical treatment of ectopic tubal pregnancy. This library of tissue and matched blood samples can then be interrogated using a variety of molecular techniques to improve understanding of regulation mechanisms of tissue receptivity to trophoblast invasion.
Protein and RNA analysis will be carried out on microdissected epithelial cells collected from the stored tubal specimens using laser capture microscopy (LCM).
The expression of the molecules of interest will be measured at the protein level by immunohistochemistry, Western blot and confocal microscopy. The gene expression of candidate molecules will be measured by RNA microarray and quantitative RT-PCR. Collected blood samples will be centrifuged 20 minutes following collection and the serum will be stored in aliquots (100 micro litres) at -20 degree Celsius till processed for ELISA to measure the concentrations of the molecules of interest.

Intervention code [1]

Not applicable

Comparator / control treatment

The study group will include women diagnosed with tubal ectopic pregnancy and undergoing surgical treatment.
The comparison group will include women with healthy Fallopian tubes obtained at tubal ligation in the absence of a pregnancy or women with healthy Fallopian tubes undergoing a hysterectomy for other non-malignant diseases.

Control group

Active

Outcomes

Primary outcome [1]

to create a bank of appropriately stored human Fallopian tube (FT) tissue from women with an unruptured ectopic pregnancy and from a healthy comparison group

Timepoint [1]

2 years

Primary outcome [2]

to reduce reliance on animal models which do not accurately mimic the human cellular phenotype and genotype, are costly and difficult to manage due to ethical dilemmas involved in animal research

Timepoint [2]

2 years

Secondary outcome [1]

a. to study the molecular basis of human embryonic implantation

Timepoint [1]