Can the levels of a cell signalling factor in menstrual blood be used as a test for endometriosis?
| ISRCTN | ISRCTN72218532 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72218532 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsors | Mohammad Hoesin Central General Hospital, Sriwijaya University |
| Funders | Universitas Sriwijaya, Investigator initiated and funded |
- Submission date
- 02/05/2023
- Registration date
- 30/06/2023
- Last edited
- 08/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Endometriosis is a benign disorder that is generally defined as the presence of endometrial glands and stroma outside their normal location. TGF-β1 is found in stromal cells and its expression is increased in epithelial cells of endometriotic cysts. Endometriosis diagnosis takes a long time, so new markers are needed to diagnose endometriosis. This study aims to determine the diagnostic value of TGF-β1 in menstrual blood for diagnosing endometriosis.
Who can participate?
Patients aged between 25–35 years old with suspected endometriosis
What does the study involve?
Diagnostic tests to compare TGF β1 levels in the menstrual blood of patients with suspected endometriosis.
What are the possible benefits and risks of participating?
The benefits are having a free TGF test and the results will present an important part of finding new screening for endometriosis. Social risks include embarrassment when collecting samples of blood.
Where is the study run from?
The Department of Obstetrics and Gynecology Dr Mohammad Hoesin General Hospital/Faculty of Medicine, Sriwijaya University, Palembang (Indonesia)
When is the study starting and how long is it expected to run for?
July 2019 to December 2020
Who is funding the study?
Investigator and Sriwijaya University initiated and funded (Indonesia)
Who is the main contact?
Mrs Excellena Nasrul, excellena90@gmail.com
Contact information
Principal investigator
Jalan Residen A. Rozak Komp. Evergreen Blok A-2 No. 1
Palembang
30163
Indonesia
| Phone | +628127100459 |
|---|---|
| kemasyusufeffendi@gmail.com |
Scientific
Jalan Batuampar III
East Jakarta
13520
Indonesia
| Phone | +6282124573473 |
|---|---|
| excellena90@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Diagnostic test of transforming growth factor-beta 1 (TGF-β1) in menstrual blood with endometriosis |
| Study acronym | DTTMBE |
| Study objectives | TGF β1 level has a very good diagnostic value in establishing an endometriosis diagnosis. |
| Ethics approval(s) | Approved 15/08/2019, Ethical Committee of Mohammad Hoesin Central General Hospital and Faculty of Medicine Sriwijaya University (Jalan Jenderal Sudirman Km 3,5, Palembang, Indonesia, 30126; +62 0711 352342; tu@unsri.ac.id), ref: 330/kepkrsmhfkunsri/2019 |
| Health condition(s) or problem(s) studied | Endometriosis |
| Intervention | Married women with suspected endometriosis aged from 25–35 years old (>35 years until before menopause), who agree to undergo operative laparoscopy, participate in the study and signed an informed consent will be included. Patients with suspected malignancy, chronic inflammation, diabetic retinopathy, pregnancy, and use of GnRH agonists before laparoscopy will be excluded from this study. In addition, the criteria for dropping out in this study were patients with blood cell lysis on examination. Withdrawal criteria in this study are subjects who refused to continue the study. Samples were collected by doing consecutive sampling. All patients who will be included in this study have anamnesis (name, age, address, parity, Last Menstrual Period (LMP), previous medical history, previous use of contraception, history of drug abuse), physical examination (general condition, blood pressure, pulse rate, respiration rate, temperature, body height, and weight). Menstrual blood samples will be collected before surgery when the patient is menstruating for the first three days and obtained through storage in the menstrual cup. Menstrual blood samples were immediately taken to the laboratory and tested for TGF β1 expression by the quantitative sandwich enzyme immunoassay method. To prepare reagents and samples, enter 50µL of assay diluent RD1-73 into each well (plate has been coated with anti-TGF β1), and add 50µL of standard, control, and activated sample to each well containing the assay diluent. Then, the procedure was continued by incubating for 2 hours, rinsing, and washing 4 times using a washing buffer, adding 100µL of the conjugate, and incubating again for 2 hours, rinsing, and washing 4 times using a washing buffer, and adding 100µL of substrate solution and incubating for 30 minutes. It should be noted to keep away from light, add 100µL of the reaction-stopping solution, and read at a wavelength of 450 nm for 30 minutes. The correction wavelength is 540 or 570 nm. Furthermore, examiners should plot the standard curve and estimate the sample concentration against the curve. Laparoscopy was performed by a Reproductive Endocrinology Fertility consultant to confirm the diagnosis and degree of endometriosis. The intraoperative findings were followed by a histopathological examination to confirm the diagnosis of endometriosis. After the data were collected, statistical analysis was performed. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Mean TGF β1 level in menstrual blood measured using enzyme-linked immunosorbent assay (ELIZA) during the first three days of menstruation |
| Key secondary outcome measure(s) |
Diagnostic accuracy of TGF β1 measured using the laparoscopy outcome of endometriosis recorded in patient medical notes at one timepoint |
| Completion date | 30/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 58 |
| Total final enrolment | 50 |
| Key inclusion criteria | Patients with suspected endometriosis who underwent laparoscopy ranging from 25–35 years of age and >35 years until before menopause, married, agreed to undergo operative laparoscopy, agreed to participate in the study and signed an informed consent |
| Key exclusion criteria | Patients with suspected malignancy, chronic inflammation, diabetic retinopathy, pregnancy, and use of GnRH agonists before laparoscopy |
| Date of first enrolment | 16/08/2019 |
| Date of final enrolment | 30/11/2020 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Palembang
30126
Indonesia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Excellena Nasrul (excellena90@gmail.com). Sharing will be limited to secondary research purposes that fall within the scope of the research described in the original consent form and for secondary research purposes that participants have not objected to. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/12/2023 | 08/01/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/01/2024: Publication reference added.
12/12/2023: The intention to publish date was changed from 30/06/2023 to 30/03/2024.
13/05/2023: Trial's existence confirmed by the Ethical Committee of Mohammad Hoesin Central General Hospital and Faculty of Medicine Sriwijaya University (Indonesia).
