A Couple-based Gender-transformative Intervention on IPV Against Infertile Women
A Couple-based Gender-transformative Intervention on Intimate Partner Violence Against Infertile Women
Peking University Third Hospital
752 participants
Jun 25, 2024
INTERVENTIONAL
Conditions
Summary
This is a multicenter, open-label, randomized controlled trial conducted at two reproductive medicine centers in Beijing, China. Couples undergoing their first or second in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle, diagnosed with female-factor infertility, and who have signed informed consent will be enrolled. Exclusion criteria include couples receiving donated oocytes, sperm, or embryos; those diagnosed with severe male-factor infertility or unexplained infertility; those undergoing preimplantation genetic testing (PGT); those who have not undergone embryo transfer within six months after oocyte retrieval; those with severe mental disorders; and those who withdraw from the study. Participants are will randomly allocated 1:1 by center to either the intervention or control group. Couples in the intervention group will receive five 60-minutes GTI sessions focusing on gender norms, gender equality, and healthy relationship skills, conducted by trained healthcare providers and social workers. The control group will receive standard reproductive care. A total of 376 infertile couples will be enrolled (188 couples per group). The primary outcome is the IPV rate against infertile women over the past 12 months.
Eligibility
Inclusion Criteria3
- Couples who are undergoing their first or second IVF/ICSI cycle;
- Couples diagnosed with female-factor infertility;
- Couples who have signed consent.
Exclusion Criteria6
- Couples who receive donated oocytes, sperm, or embryos;
- Couples diagnosed with severe male-factor infertility or unexplained infertility.
- Couples who are undergoing Preimplantation Genetic Testing (PGT);
- Couples who have not undergone embryo transfer within six months after oocyte retrieval;
- Couples who have severe mental disorders;
- Couples who withdrew from the study.
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Interventions
A multidisciplinary team of experts, including 8-10 experts in reproductive medicine, nursing, social work, psychiatry, family law, and evidence-based medicine, will be established to support the development of the intervention. Five 60-minutes intervention sessions will be delivered by trained nurses and social workers throughout participants' fertility treatment cycle. Intervention will be carried out at the 5 critical windows of opportunity for infertility treatment: (1) before entering the cycle; (2) during follicular monitoring; (3) before oocyte retrieval; and (4) 2 weeks after the embryo transfer; and (5) 28-30 days after the embryo transfer. The intervention components will equip couples with educational information on health and relationship and skills obtained from interactive activities designed with an explicit focus on challenging gender stereotypes, all of which could incite reflection on sociocultural norms and gender-related power inequality.
Locations(2)
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NCT06124950