Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06124950

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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