Actively Recruiting
A Couple-based Gender-transformative Intervention on IPV Against Infertile Women
Led by Peking University Third Hospital · Updated on 2024-08-28
752
Participants Needed
2
Research Sites
105 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
B
Beijing Obstetrics and Gynecology Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Couple-based Gender-transformative Intervention on IPV Against Infertile Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Couples who are undergoing their first or second IVF/ICSI cycle
- Couples diagnosed with female-factor infertility
- Couples who have signed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Obstetrics and Gynecology Hospital
Beijing, China
Not Yet Recruiting
2
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yu Fu, MS
CONTACT
Y
Yuanyuan Wang, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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