A Couple-based Gender-transformative Intervention on IPV Against Infertile Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Third Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Couples who are undergoing their first or second IVF/ICSI cycle;
Couples diagnosed with female-factor infertility;
Couples who have signed consent.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Gender-transformative intervention
BehavioralA 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.
Treatment groups
752 Participants
are divided into 2 treatment groupsGroup A: GTI InterventionExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Past-12-months Intimate Partner Violence against infertile women
Past-12-months prevalence of IPV against infertile women measured using an instrument that combined the Revised Conflict Tactics Scale (CTS-2) and the Scale of Economic Abuse-12 (SEA-12). Respondents will be asked if they had experienced any specific acts of physical (6 items from CTS-2 injury subscale, 12 from CTS-2 physical assault subscale), psychological (8 items from CTS-2 psychological aggression subscale), sexual (7 items from CTS-2 sexual coercion subscale), or economic violence (12 items from SEA-12) in the past 12 months. The past-12-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 12 months.
Time frame
T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)Secondary outcomes
1
Past-12-months Intimate Partner Violence against male partners
Past-12-months prevalence of IPV against male partners measured using an instrument that combined the Revised Conflict Tactics Scale (CTS-2) and the Scale of Economic Abuse-12 (SEA-12). Respondents will be asked if they had experienced any specific acts of physical (6 items from CTS-2 injury subscale, 12 from CTS-2 physical assault subscale), psychological (8 items from CTS-2 psychological aggression subscale), sexual (7 items from CTS-2 sexual coercion subscale), or economic violence (12 items from SEA-12) in the past 12 months. The past-12-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 12 months.
Time frame
T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)2
Past-3-months Intimate Partner Violence against infertile women
Past-3-months prevalence of IPV against infertile women measured using the World Health Organization Violence Against Women (WHO-VAW) Instrument. The WHO-VAW has 6 items asking if participants had experienced any specific acts of physical (1 item), sexual (1 item), and psychological (4 items) violence in the past 3 months. The past-3-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 3 months.
Time frame
T0 (Baseline); T0 + ~2months (28-30 days after embryo transfer); T0 + ~4 months (12-13 weeks of gestation); T0 + ~12-14 months (4 weeks after delivery)3
Past-3-months Intimate Partner Violence against male partners
Past-3-months prevalence of IPV against male partners measured using the World Health Organization Violence Against Women (WHO-VAW) Instrument. The WHO-VAW has 6 items asking if participants had experienced any specific acts of physical (1 item), sexual (1 item), and psychological (4 items) violence in the past 3 months. The past-3-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 3 months.
Time frame
T0 (Baseline); T0 + ~2months (28-30 days after embryo transfer); T0 + ~4 months (12-13 weeks of gestation); T0 + ~12-14 months (4 weeks after delivery)4
Past-12-months Severe Intimate Partner Violence against infertile women
Past-12-months prevalence of severe IPV against infertile women measured using an instrument that combined the Revised Conflict Tactics Scale (CTS-2) and the Scale of Economic Abuse-12 (SEA-12). Respondents will be asked if they had experienced any specific acts of physical (6 items from CTS-2 injury subscale, 12 from CTS-2 physical assault subscale), psychological (8 items from CTS-2 psychological aggression subscale), sexual (7 items from CTS-2 sexual coercion subscale), or economic violence (12 items from SEA-12) in the past 12 months. Severe IPV is defined as any reported instance of physical or sexual violence (regardless of frequency) and/or any psychological or economic violence ≥ 3 times in the past year. The past-12-months prevalence of severe IPV is calculated as the proportion of participants reporting at least one severe IPV in the past 12 months.
Time frame
T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University Third Hospital
Lead sponsor
Beijing Obstetrics and Gynecology Hospital
Collaborator
Source ClinicalTrials.gov