Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06124950

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

Led by Peking University Third Hospital · Updated on 2024-08-28

752

Participants Needed

2

Research Sites

N/A

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 research aims to evaluate a gender-transformative intervention designed to reduce intimate partner violence (IPV) against infertile women. It focuses on couples diagnosed with female-factor infertility undergoing their first or second IVF or ICSI cycle. The trial addresses the overlap between infertility and IPV, recognizing that infertile women face higher risks of IPV and that their needs have often been overlooked. Participants are randomly assigned to one of two groups. The intervention group receives five 60-minute sessions led by trained nurses and social workers throughout the fertility treatment cycle. These sessions cover gender norms, gender equality, and healthy relationship skills at key treatment stages: before the cycle starts, during follicular monitoring, before oocyte retrieval, two weeks after embryo transfer, and 28-30 days post-transfer. The control group receives standard reproductive care. A total of 376 couples will participate, split evenly between the two groups. During the study, couples will undergo assessments at baseline and multiple points up to about 14 months after delivery. Researchers will measure the rate of IPV against infertile women over the past 12 months as the primary outcome. Secondary assessments include IPV against male partners, attitudes toward gender roles, marital quality, coping with stress, patient satisfaction with treatment, pregnancy outcomes, and neonatal health. This comprehensive follow-up includes questionnaires, clinical pregnancy tests, and monitoring of birth outcomes to understand the intervention's impact over time.

CONDITIONS

Brief 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 undergoing their first or second IVF or ICSI cycle
  • Couples diagnosed with female-factor infertility
  • Couples who have signed informed consent
Not Eligible

You will not qualify if you...

  • Couples receiving donated oocytes, sperm, or embryos
  • Couples diagnosed with severe male-factor infertility or unexplained infertility
  • Couples undergoing Preimplantation Genetic Testing (PGT)
  • Couples who have not undergone embryo transfer within six months after oocyte retrieval
  • Couples with severe mental disorders
  • Couples who withdrew from the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Outpatient Treatment

Duration - Duration of fertility treatment cycle (approximately 1.5 to 2 months)

Participants receive five 60-minute gender-transformative intervention sessions delivered by trained nurses and social workers throughout their fertility treatment cycle. These sessions focus on educational information and interactive activities to challenge gender stereotypes and promote reflection on sociocultural norms and gender-related power inequality.

5 sessions at specific fertility treatment timepoints

Long-term Monitoring

Duration - Up to ~14 months after baseline

Participants are followed for up to approximately 14 months after baseline to assess intimate partner violence, pregnancy outcomes, and other related measures.

Assessments at baseline, ~2 months, ~4 months, and ~14 months after baseline

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

Y

Yuanyuan Wang, Dr

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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