A Couple-based Gender-transformative Intervention on IPV Against Infertile Women

Recruiting now · Not applicable

Conditions studied: Infertility, Female, Violence, Domestic

In brief

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.

Key facts

Study ID

NCT06124950

Run by

Peking University Third Hospital

People needed

752

Starts

2024-06-25

Expected to finish

2026-07-01

Last updated by the study team

2024-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Couples who are undergoing their first or second IVF/ICSI cycle;
• Couples diagnosed with female-factor infertility;
• Couples who have signed consent.

You may not qualify if…

• 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.

Where it is running

• Peking University Third Hospital — Beijing, China (enrolling)
• Beijing Obstetrics and Gynecology Hospital — Beijing, China

Full record on ClinicalTrials.gov

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