A Couple-based Gender-transformative Intervention on Intimate Partner Violence Against Infertile Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 752
- 试验地点
- 2
- 主要终点
- Past-12-months Intimate Partner Violence against infertile women
研究概览
简要总结
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.
详细描述
Infertility and intimate partner violence (IPV) are significant challenges in sexual and reproductive health, with a notable intersection as infertile women face higher IPV risks. However, the needs of infertile couples have been largely overlooked, and the effectiveness of gender-transformative interventions (GTIs) designed to challenge gender inequality and question gender norms in reducing IPV against infertile women has not been evaluated.
This is a multicenter, open-label, randomized controlled trial conducted at two reproductive medicine centers in Beijing, China (the Centers for Reproductive Medicine of Peking University Third Hospital and Beijing Obstetrics and Gynecology Hospital).
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 GTI sessions will be delivered by trained nurses and social workers throughout participants' fertility treatment cycle. Intervention will be carried out at the 4 critical windows of opportunity for infertility treatment: (1) before entering the cycle; (2) during follicular monitoring; (3) the oocyte retrieval-embryo transfer phase; (4) 2 weeks after the embryo transfer (hCG pregnancy test), 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.
Participants are will randomly allocated 1:1 by center to either the intervention or control group. Couples in the intervention group will receive GTI sessions. The control group will receive standard reproductive care. A total of 376 infertile couples will be enrolled (188 couples per group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Couples who are undergoing their first or second IVF/ICSI cycle;
- •Couples diagnosed with female-factor infertility;
- •Couples who have signed consent.
排除标准
- •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.
结局指标
主要结局
Past-12-months Intimate Partner Violence against infertile women
时间窗: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
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.
次要结局
- Ectopic pregnancy(7 weeks of gestation)
- Birth weight(Within the first hour after live birth)
- Past-3-months Intimate Partner Violence against infertile women(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))
- Patient satisfaction with infertility treatment(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))
- Clinical pregnancy(T0 + ~2 months (28-30 days after embryo transfer))
- Live birth(After 22 weeks of gestation)
- Past-12-months Intimate Partner Violence against male partners(T0 (Baseline) and T0 + ~14 months (4 weeks after delivery))
- Past-12-months Severe Intimate Partner Violence against infertile women(T0 (Baseline) and T0 + ~14 months (4 weeks after delivery))
- Biochemical Pregnancy Loss(T0 + 1.5-2 months)
- Stillbirth(After 22 weeks of gestation)
- Past-3-months Intimate Partner Violence against male partners(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))
- Past-12-months severe Intimate Partner Violence against male partners(T0 (Baseline) and T0 + ~14 months (4 weeks after delivery))
- Attitudes toward male gender roles(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))
- Martial quality and satisfaction(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))
- Couples' coping with stress(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))
- Human chorionic gonadotropin (hCG) Positive(T0 + ~1.5 months)
- Ongoing pregnancy(T0 + ~4 months (12 weeks after embryo transfer))
- Miscarriage(22 weeks of gestation)
- Cycle cancellation(T0 + ~2 months)
- Preterm birth(28-37 weeks of pregnancy)
- Congenital anomaly(Within 2 weeks after live birth)
- Neonatal mortality(Within 28 days of birth)
研究者
Jie Qiao
Chief Physician
Peking University Third Hospital