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

Study Overview
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Brief Summary
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This multicenter, two-arm, open-label, cluster-randomized controlled trial will be conducted in two hospitals in China, focusing on couples with primary female-factor infertility who are undergoing their 1st or 2nd In Vitro Fertilization and Embryo Transfer (IVF-ET) treatments. Evidence suggests that infertile women have a higher risk of experiencing Intimate Partner Violence (IPV). The trial aims to develop and evaluate a couple-based Gender-Transformative Intervention (GTI) for infertile couples to reduce IPV prevalence. Approximately 240 couples (120 per group) will be enrolled. Clusters (6 couples/cluster) will be allocated to two groups at a ratio of 1:1- GTI group and standard care group. All clusters will be randomized through stratified block randomization according to the study sites. The intervention involves educating couples about reproductive health and intimate relationships, fostering gender equality awareness, and promoting mutual understanding and support. Researchers will compare the intervention group to a control group to see if the GTI intervention results in a reduced prevalence rate of IPV and improvements in the secondary outcomes including the attitude towards male gender roles, marital quality and satisfaction, clinical pregnancy rate, and ongoing pregnancy rate.

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

Conditions
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Infertility, Female, Violence, Domestic

Intervention / Treatment
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* Behavioral: Gender-transformative intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Couples who are undergoing their first or second IVF-ET cycle; Couples who are receiving a fresh embryo; Couples with primary infertility; Couples with female-factor infertility; Couples who have signed consent Exclusion Criteria: Couples who receive donated oocytes, sperm, or embryos; Couples with male-factor infertility or unexplained infertility; Couples who are undergoing Preimplantation Genetic Testing (PGT); Couples who change from a fresh cycle to a freeze-thaw cycle; Couples who have severe mental disorders; Couples who withdrew from the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GTI Intervention<br>Participants will be provided with five GTI sessions (60-75 minutes/session). | Behavioral: Gender-transformative intervention<br>* The GTI intervention will be delivered by trained nurses and social workers throughout participants' fertility treatment cycle. 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 inequality.<br>|
| No Intervention: Standard Care<br>Standard clinical procedures for assisted reproduction and health education | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Past-12-months Intimate Partner Violence against infertile women | Past-12-months prevalence of past-12-months IPV against infertile women measured by a standardized instrument | T0 (Baseline); T0 +  2months (28-30 days after embryo transfer); T0 +  4 months (12-13 weeks of gestation); T0 +  14 months (4 weeks after delivery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Past-12-months Intimate Partner Violence against male partners | Past-12-months prevalence of IPV against male partners measured by a standardized instrument | T0 (Baseline); T0 +  2months (28-30 days after embryo transfer); T0 +  4 months (12-13 weeks of gestation); T0 +  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 by a standardized instrument; 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. | T0 (Baseline); T0 +  2months (28-30 days after embryo transfer); T0 +  4 months (12-13 weeks of gestation); 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 by a standardized instrument; 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. | T0 (Baseline); T0 +  2months (28-30 days after embryo transfer); T0 +  4 months (12-13 weeks of gestation); T0 +  14 months (4 weeks after delivery) | 
| Attitudes toward male gender roles | Measured by the Male Role Attitudes Scale (MRAS) to assess infertile couples' attitudes towards traditional male role stereotypes | T0 (Baseline); T0 +  2months (28-30 days after embryo transfer); T0 +  4 months (12-13 weeks of gestation); T0 +  14 months (4 weeks after delivery) | 
| Martial quality and satisfaction | Measured by the Relationship Assessment Scale (RAS) | T0 (Baseline); T0 +  2months (28-30 days after embryo transfer); T0 +  4 months (12-13 weeks of gestation); T0 +  14 months (4 weeks after delivery) | 
| Couples' coping with stress and patient satisfaction | Measured by two items from the Dyadic Coping Inventory (DCI) and one item from the patient satisfaction survey | T0 (Baseline); T0 +  2months (28-30 days after embryo transfer); T0 +  4 months (12-13 weeks of gestation); T0 +  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) | 
| Miscarriage | Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age | 22 weeks of gestation | 
| 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 | 
| Ectopic pregnancy | Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy | 7 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 +  1 months | 
| 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 | 
| 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 | 
| 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 |