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

NCT06124950 | Recruiting DMC

• 1 other identifier: M2023460
• Study Type: interventional
• Target: 752
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Infertility, Female; Violence, Domestic

Outcome Measures

Primary Outcomes (1)

• Past-12-months Intimate Partner Violence against infertile women

  Past-12-months prevalence of IPV against infertile women measured using an instrument that combined the Revised Conflict Tactics Scale (CTS-2) and the Scale of Economic Abuse-12 (SEA-12). Respondents will be asked if they had experienced any specific acts of physical (6 items from CTS-2 injury subscale, 12 from CTS-2 physical assault subscale), psychological (8 items from CTS-2 psychological aggression subscale), sexual (7 items from CTS-2 sexual coercion subscale), or economic violence (12 items from SEA-12) in the past 12 months. The past-12-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 12 months.

  T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)

Secondary Outcomes (22)

• Past-12-months Intimate Partner Violence against male partners

  T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)

• Past-3-months Intimate Partner Violence against infertile women

  T0 (Baseline); T0 + ~2months (28-30 days after embryo transfer); T0 + ~4 months (12-13 weeks of gestation); T0 + ~12-14 months (4 weeks after delivery)

• Past-3-months Intimate Partner Violence against male partners

  T0 (Baseline); T0 + ~2months (28-30 days after embryo transfer); T0 + ~4 months (12-13 weeks of gestation); T0 + ~12-14 months (4 weeks after delivery)

• Past-12-months Severe Intimate Partner Violence against infertile women

  T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)

• Past-12-months severe Intimate Partner Violence against male partners

  T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)

Study Arms (2)

GTI Intervention

EXPERIMENTAL

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.

Behavioral: Gender-transformative intervention

Standard Care

NO INTERVENTION

Participants in the intervention group will be provided with standard clinical procedures for assisted reproduction and health education.

Interventions

Gender-transformative intervention BEHAVIORAL

A multidisciplinary team of experts, including 8-10 experts in reproductive medicine, nursing, social work, psychiatry, family law, and evidence-based medicine, will be established to support the development of the intervention. Five 60-minutes intervention sessions will be delivered by trained nurses and social workers throughout participants' fertility treatment cycle. Intervention will be carried out at the 5 critical windows of opportunity for infertility treatment: (1) before entering the cycle; (2) during follicular monitoring; (3) before oocyte retrieval; and (4) 2 weeks after the embryo transfer; and (5) 28-30 days after the embryo transfer. The intervention components will equip couples with educational information on health and relationship and skills obtained from interactive activities designed with an explicit focus on challenging gender stereotypes, all of which could incite reflection on sociocultural norms and gender-related power inequality.

GTI Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Obstetrics and Gynecology Hospital: collaborator

Study Sites (2)

Beijing Obstetrics and Gynecology Hospital

Beijing, China

NOT YET RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Jie Qiao, Dr

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Fu, MS

CONTACT

+86 13521777668; annyfy0417@gmail.com

Yuanyuan Wang, Dr

CONTACT

+86 13811352300; yyuanwang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 9, 2023
• Study Start: June 25, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)