A Couple-based Gender-transformative Intervention on Intimate Partner Violence Against Infertile Women

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Couples who are undergoing their first or second IVF/ICSI cycle;

• Couples diagnosed with female-factor infertility;

• Couples who have signed consent.

Locations
Other Locations
China
Beijing Obstetrics and Gynecology Hospital
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Contact Information
Primary
Yu Fu, MS
annyfy0417@gmail.com
+86 13521777668
Backup
Yuanyuan Wang, Dr
yyuanwang@163.com
+86 13811352300
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2026-07
Participants
Target number of participants: 752
Treatments
Experimental: GTI Intervention
Participants in the intervention group will be provided with five GTI sessions (60-minutes/session) by trained nurses and social workers throughout participants' fertility treatment cycle throughout participants' fertility treatment cycle.
No_intervention: Standard Care
Participants in the intervention group will be provided with standard clinical procedures for assisted reproduction and health education.
Related Therapeutic Areas
Sponsors
Leads: Peking University Third Hospital
Collaborators: Beijing Obstetrics and Gynecology Hospital

This content was sourced from clinicaltrials.gov