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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Violence, Domestic; Infertility, Female
• Intervention / Treatment: Behavioral: Gender-transformative intervention

Detailed Description

Infertility and intimate partner violence (IPV) are significant challenges in sexual and reproductive health, with a notable intersection as infertile women face higher IPV risks. However, the needs of infertile couples have been largely overlooked, and the effectiveness of gender-transformative interventions (GTIs) designed to challenge gender inequality and question gender norms in reducing IPV against infertile women has not been evaluated.

This is a multicenter, open-label, randomized controlled trial conducted at two reproductive medicine centers in Beijing, China (the Centers for Reproductive Medicine of Peking University Third Hospital and Beijing Obstetrics and Gynecology Hospital).

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 GTI sessions will be delivered by trained nurses and social workers throughout participants' fertility treatment cycle. Intervention will be carried out at the 4 critical windows of opportunity for infertility treatment: (1) before entering the cycle; (2) during follicular monitoring; (3) the oocyte retrieval-embryo transfer phase; (4) 2 weeks after the embryo transfer (hCG pregnancy test), 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.

Participants are will randomly allocated 1:1 by center to either the intervention or control group. Couples in the intervention group will receive GTI sessions. The control group will receive standard reproductive care. A total of 376 infertile couples will be enrolled (188 couples per group).

• Study Type: Interventional
• Enrollment (Estimated): 752
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Fu, MS; Phone Number: +86 13521777668; Email: annyfy0417@gmail.com
• Study Contact Backup: Name: Yuanyuan Wang, Dr; Phone Number: +86 13811352300; Email: yyuanwang@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Yu Fu, MS; Phone Number: +8613521777668; Email: annyfy0417@gmail.com
  • Beijing, China
    • Not yet recruiting
    • Beijing obstetrics and gynecology hospital
    • Contact: Xiaokui Yang, Dr; Phone Number: +8613718193183
    • Contact: Ying Fang, Dr; Phone Number: +8613552326071

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Couples who are undergoing their first or second IVF/ICSI cycle;
• Couples diagnosed with female-factor infertility;
• Couples who have signed consent.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Gender-transformative intervention; 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.
No Intervention: Standard Care; Participants in the intervention group will be provided with standard clinical procedures for assisted reproduction and health education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Miscarriage	Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age.	22 weeks of gestation
Ectopic pregnancy	Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy.	7 weeks of gestation
Preterm birth	Birth of a fetus delivered after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy.	28-37 weeks of pregnancy
Congenital anomaly	Any congenital anomaly will be included, including structural or chromosomal abnormalities of the fetus in utero, Trisomy 21 (Down syndrome), congenital heart disease, neural tube defects, cleft lip and palate, polydactyly, hydrocephalus, etc.	Within 2 weeks after live birth
Neonatal mortality	Death of a live born baby within 28 days of birth	Within 28 days of birth
Past-12-months Intimate Partner Violence against male partners	Past-12-months prevalence of IPV against male partners 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)
Past-3-months Intimate Partner Violence against infertile women	Past-3-months prevalence of IPV against infertile women measured using the World Health Organization Violence Against Women (WHO-VAW) Instrument. The WHO-VAW has 6 items asking if participants had experienced any specific acts of physical (1 item), sexual (1 item), and psychological (4 items) violence in the past 3 months. The past-3-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 3 months.	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	Past-3-months prevalence of IPV against male partners measured using the World Health Organization Violence Against Women (WHO-VAW) Instrument. The WHO-VAW has 6 items asking if participants had experienced any specific acts of physical (1 item), sexual (1 item), and psychological (4 items) violence in the past 3 months. The past-3-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 3 months.	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	Past-12-months prevalence of severe 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. Severe IPV is defined as any reported instance of physical or sexual violence (regardless of frequency) and/or any psychological or economic violence ≥ 3 times in the past year. The past-12-months prevalence of severe IPV is calculated as the proportion of participants reporting at least one severe IPV in the past 12 months.	T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
Past-12-months severe Intimate Partner Violence against male partners	Past-12-months prevalence of severe IPV against male partners 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. Severe IPV is defined as any reported instance of physical or sexual violence (regardless of frequency) and/or any psychological or economic violence ≥ 3 times in the past year. The past-12-months prevalence of severe IPV is calculated as the proportion of participants reporting at least one severe IPV in the past 12 months.	T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
Attitudes toward male gender roles	Attitudes toward male gender roles measured by the Male Role Attitudes Scale (MRAS) to assess infertile couples' attitudes towards traditional male role stereotypes. The MRAS has 8 items. Responses to the MRAS were based on a four-point Likert scale from 'strongly disagree=1' to 'strongly agree=4'. A total score was derived by totalling responses to each item, giving a possible score of 8-32, where higher scores indicate greater endorsement of traditional male role stereotypes.	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)
Martial quality and satisfaction	Martial quality and satisfaction measured by the Relationship Assessment Scale (RAS). The RAS has 7 items. Responses to the RAS were based on a five-point Likert scale from 'low=1' to 'high=5'. Items 4 and 7 are reverse-scored. A total score was derived by totalling responses to each item, giving a possible score of 7-35. The higher the score, the more satisfied the respondent is with his/her relationship.	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)
Couples' coping with stress	Couples' coping with stress was measured by two items from the Dyadic Coping Inventory (DCI). Responses to the DCI were based on a five-point Likert scale ranging from 'strongly disagree = 1' to 'strongly agree = 5'.A total score was derived by totalling responses to each item, giving a possible score of 2-10. A higher score indicates couple's better dyadic coping with stress.	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)
Patient satisfaction with infertility treatment	Patient satisfaction was measured by one item from the patient satisfaction survey. Responses to this question were based on a five-point Likert scale ranging from 'strongly disagree = 1' to 'strongly agree = 5'. The score ranged from 1 to 5, with a higher score indicating greater satisfaction with the infertility treatment.	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)
Human chorionic gonadotropin (hCG) Positive	Positive for Beta-human chorionic gonadotropin (βhCG) in blood or urine after embryo transfer.	T0 + ~1.5 months
Clinical pregnancy	One or more observed gestational sac or definitive clinical signs of pregnancy under ultrasonography at 28-30 days after embryo transfer (including clinically documented ectopic pregnancy).	T0 + ~2 months (28-30 days after embryo transfer)
Ongoing pregnancy	Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.	T0 + ~4 months (12 weeks after embryo transfer)
Biochemical Pregnancy Loss	Positive for hCG after embryo transfer, but no clinical pregnancy observed.	T0 + 1.5-2 months
Stillbirth	Fetal death after 22 weeks of gestation, with no signs of life such as heartbeat, breathing, umbilical cord pulse, or voluntary muscle contraction.	After 22 weeks of gestation
Live birth	A delivery of one or more living infants (≥22 weeks gestation or birth weight more than 1,000g).	After 22 weeks of gestation
Cycle cancellation	The cycle is considered canceled if any of the following situations occur from the ovarian stimulation to the embryo transfer: The researcher determines that by the 20th day of ovarian stimulation, there are not ≥2 follicles with a diameter of ≥18mm.; Ultrasound reveals more than 25 follicles with a diameter of ≥12mm.; No oocytes are retrieved on the egg retrieval day.; No transferable embryos are available on the transfer day.; Ovarian Hyperstimulation Syndrome (OHSS) occurs during the ovarian stimulation process.; The participant requests to cancel the cycle or the researcher cancels the cycle for other valid reasons.	T0 + ~2 months
Birth weight	The weight measured for the first time within the first hour after birth. High birth weight: ≥4kg; Low birth weight: < 2.5kg.	Within the first hour after live birth

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beijing Obstetrics and Gynecology Hospital
• Investigators: Principal Investigator: Jie Qiao, Dr, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: M2023460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Given the nature of the study, individual participant data (IPD) will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No