A Couple-based Gender-transformative Intervention on IPV Against Infertile Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gender-transformative intervention.
- Who it may be relevant to
- Registry conditions: Infertility, Female, Violence, Domestic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Couple-based Gender-transformative Intervention on Intimate Partner Violence Against Infertile Women
Overview
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.
Detailed description
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).
Interventions
- Behavioral Gender-transformative intervention
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
Primary outcome measures
- Past-12-months Intimate Partner Violence against infertile women [Time frame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)]
Secondary outcome measures (12)
- Past-12-months Intimate Partner Violence against male partners [Time frame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)]
- Past-3-months Intimate Partner Violence against infertile women [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)]
- Past-3-months Intimate Partner Violence against male partners [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)]
- Past-12-months Severe Intimate Partner Violence against infertile women [Time frame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)]
- Past-12-months severe Intimate Partner Violence against male partners [Time frame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)]
- Attitudes toward male gender roles [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)]
- Martial quality and satisfaction [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)]
- Couples' coping with stress [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)]
- Patient satisfaction with infertility treatment [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)]
- Human chorionic gonadotropin (hCG) Positive [Time frame: T0 + ~1.5 months]
- Clinical pregnancy [Time frame: T0 + ~2 months (28-30 days after embryo transfer)]
- Ongoing pregnancy [Time frame: T0 + ~4 months (12 weeks after embryo transfer)]
Eligibility criteria
Inclusion criteria
- Couples who are undergoing their first or second IVF/ICSI cycle;
- Couples diagnosed with female-factor infertility;
- Couples who have signed consent.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
China · 2 centers
- Beijing Obstetrics and Gynecology Hospital — Beijing
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT06124950 · M2023460