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Association between individual-level socioeconomic factors and intimate partner violence victimisation in women: a systematic review protocol

Por: Reyal · H. P. · Dissanayake · N. · Gunarathna · H. · Soysa · D. · Fernando · M. S. · Senarathna · L.
Introduction

Intimate partner violence (IPV) is a global public health problem. Although both men and women experience IPV, the burden is more on women. To address IPV effectively, it is important to understand the factors that cause IPV including the socioeconomic factors. However, there is an inadequacy of knowledge on how socioeconomic factors at different levels affect IPV. Hence, the objective is to review the individual-level socioeconomic factors associated with IPV victimisation of women and girls.

Methods and analysis

The search strategy was developed to identify publications from January 2010 to 30 June 2024. The selected electronic databases of PubMed/MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, Scopus and Science Direct will be searched. The eligibility criteria for data collection are based on participants/population (women and girls), exposure (socioeconomic factors) and outcome (IPV). In primary search, the title and abstracts will be screened and reference lists of selected articles will be screened for additional studies. Two researchers will independently screen the articles, and in any disagreements, a third researcher will be consulted. The data will be tabulated to present the study and participant characteristics, comparison descriptors between victims and non-victims, inclusion and exclusion criteria, primary and secondary outcomes data, results, limitations and implications. A quality assessment will be performed on the selected studies to avoid bias. A narrative synthesis will summarise the findings.

Ethics and dissemination

Ethical approval was waived because only secondary data are used. The protocol will be published, and the findings will be disseminated via publication in a peer-reviewed journal.

PROSPERO registration number

CRD42022373535.

ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden--a phase III randomised double-blinded placebo-controll

Por: Rodriguez-Wallberg · K. A. · Nilsson · H. P. · Bergh · J. · Malmros · J. · Ljungman · P. · Foukakis · T. · Stragliotto · C. L. · Friman · E. I. · Linderholm · B. · Valachis · A. · Andersson · A. · Harrysson · S. · Vennström · L. · Frisk · P. · Mörse · H. · Eloranta · S.
Background

Gonadotropin-releasing hormone agonists (GnRHa) cotreatment used to transiently suppress ovarian function during chemotherapy to prevent ovarian damage and preserve female fertility is used globally but efficacy is debated. Most clinical studies investigating a beneficial effect of GnRHa cotreatment on ovarian function have been small, retrospective and uncontrolled. Unblinded randomised studies on women with breast cancer have suggested a beneficial effect, but results are mixed with lack of evidence of improvement in markers of ovarian reserve. Unblinded randomised studies of women with lymphoma have not shown any benefit regarding fertility markers after long-term follow-up and no placebo-controlled study has been conducted so far. The aim of this study is to investigate if administration of GnRHa during cancer treatment can preserve fertility in young female cancer patients in a double-blind, placebo-controlled clinical trial.

Methods and analysis

A prospective, randomised, double-blinded, placebo-controlled, phase III study including 300 subjects with breast cancer. In addition, 200 subjects with lymphoma, acute leukemias and sarcomas will be recruited. Women aged 14–42 will be randomised 1:1 to treatment with GnRHa (triptorelin) or placebo for the duration of their gonadotoxic chemotherapy. Follow-up until 5 years from end of treatment (EoT). The primary endpoint will be change in anti-Müllerian hormone (AMH) recovery at follow-up 12 months after EoT, relative to AMH levels at EoT, comparing the GnRHa group and the placebo group in women with breast cancer.

Ethics and dissemination

This study is designed in accordance with the principles of Good Clinical Practice (ICH-GCP E6 (R2)), local regulations (ie, European Directive 2001/20/EC) and the ethical principles of the Declaration of Helsinki. Within 6 months of study completion, the results will be analysed and the study results shall be reported in the EudraCT database.

Study registration

The National Institutional review board in Sweden dnr:2021–03379, approval date 12 October 2021 (approved amendments 12 June 2022, dnr:2022-02924-02 and 13 December 2022, dnr:2022-05565-02). The Swedish Medical Product Agency 19 January 2022, Dnr:5.1-2021-98927 (approved amendment 4 February 2022). Manufacturing authorisation for authorised medicinal products approved 6 December 2021, Dnr:6.2.1-2020-079580. Stockholm Medical Biobank approved 22 June 2022, RBC dnr:202 253.

Trial registration number

NCT05328258; EudraCT number:2020-004780-71.

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