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Establishing an open access Biobank of human Fallopian tubes

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12613000221752
Enrollment
150
Registered
2013-02-25
Start date
2013-02-26
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Ectopic pregnancy is an unpredictable, non-viable and potentially life-threatening condition caused by ectopic (abnormal) implantation of an early embryo into the Fallopian tube instead of the uterus (womb). Ectopic pregnancy occurs in about 2% of pregnancies in Australia. Recent research by our group and others has suggested possible reasons for the embryo failing to implant in the correct place in ectopic pregnancy. To allow us to study this further, we are setting up a bank of stored Fallopian tube tissue collected from women who are having the tube removed as treatment for an ectopic pregnancy. To study possible causes of miscarriage and infertility we will compare affected Fallopian tubes to healthy Fallopian tubes obtained from women who are having operation for non-malignant disease or tubal ligation. A Fallopian tube removed during surgery is not usually kept once it has been examined for diagnosis. We have set up a process by which we can collect and appropriately store the tissue after it is examined by the pathologist. The Biobank of human Fallopian tubes, a repository of disease-specific human samples will promote cutting edge biomedical research in the area of fertility, early embryogenesis and implantation, human reproduction, and carcinogenesis by decreasing reliance on animal models and allowing open access to human samples for scientists. The open access Biobank of human Fallopian tubes will facilitate data dissemination and will help to generate more studies refining methodologies in human research.

Interventions

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 couple

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.

Sponsors

NHMRC
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
21 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria for study group: Sex: female Age range: 21- 50 Disease status: unruptured ectopic pregnancy with stable vital signs Concomitant disease status: Laboratory parameters: positive bHCG Others: ultrasound Willingness to give written or oral informed consent and willingness to participate to and comply with the study. Ability to understand spoken and written English, able to consent for research. The comparison group will include women having hysterectomy for benign disease or a sterilization procedure

Exclusion criteria

Exclusion criteria for participants in study group: Patients with a significant degree of pain due to ectopic pregnancy Patients with unstable vital signs Patients who expressed desire not to participate in research Patients who unable to understand the requirements of the study Exclusion criteria for participants in comparison group: Patients who are not willing to participate in research Patients who are not able to give written informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026