A Couple-based Gender-transformative Intervention on IPV Against Infertile Women
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GTI Intervention Participants will be provided with five GTI sessions (60-75 minutes/session). |
Behavioral: Gender-transformative intervention
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.
|
| No Intervention: Standard Care Standard clinical procedures for assisted reproduction and health education |
Outcome Measures
Primary Outcome Measures
- 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 + ~14 months (4 weeks after delivery)]
Prevalence of IPV against infertile women measured by a standardized instrument
Secondary Outcome Measures
- 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 + ~14 months (4 weeks after delivery)]
Prevalence of IPV against male partners measured by a standardized instrument
- Attitudes toward male gender roles [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)]
Measured by the "Male Role Attitudes Scale (MRAS)" to assess infertile couples' attitudes towards traditional male role stereotypes
- Martial quality and satisfaction [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)]
Measured by the "Relationship Assessment Scale (RAS)"
- Couples' coping with stress and patient satisfaction [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)]
Measured by two items from the "Dyadic Coping Inventory (DCI)" and one item from the patient satisfaction survey
- Human chorionic gonadotropin (hCG) Positive [T0 + ~1.5 months]
Positive for Beta-human chorionic gonadotropin (βhCG) in blood or urine after embryo transfer
- Clinical pregnancy [T0 + ~2 months (28-30 days after embryo transfer)]
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)
- Ongoing pregnancy [T0 + ~4 months (12 weeks after embryo transfer)]
Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation
- Miscarriage [22 weeks of gestation]
Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age
- Biochemical Pregnancy Loss [T0 + 1.5-2 months]
Positive for hCG after embryo transfer, but no clinical pregnancy observed
- Stillbirth [After 28 weeks of gestation]
Fetal death after 28 weeks of gestation, with no signs of life such as heartbeat, breathing, umbilical cord pulse, or voluntary muscle contraction
- Live birth [After 22 weeks of gestation]
A delivery of one or more living infants (≥22 weeks gestation or birth weight more than 1,000g)
- Ectopic pregnancy [7 weeks of gestation]
Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy
- Cycle cancellation [T0 + ~1 months]
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.
- Preterm birth [28-37 weeks of pregnancy]
Birth of a fetus delivered after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy
- Birth weight [Within the first hour after live birth]
The weight measured for the first time within the first hour after birth. High birth weight: ≥4kg; Low birth weight: < 2.5kg
- Congenital anomaly [Within 2 weeks after live birth]
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.
- Neonatal mortality [Within 28 days of birth]
Death of a live born baby within 28 days of birth
Eligibility Criteria
Criteria
Inclusion Criteria:
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Couples who are undergoing their first or second IVF-ET cycle;
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Couples who are receiving a fresh embryo;
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Couples with primary infertility;
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Couples with female-factor infertility;
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Couples who have signed consent
Exclusion Criteria:
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Couples who receive donated oocytes, sperm, or embryos;
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Couples with male-factor infertility or unexplained infertility;
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Couples who are undergoing Preimplantation Genetic Testing (PGT);
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Couples who change from a fresh cycle to a freeze-thaw cycle;
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Couples who have severe mental disorders;
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Couples who withdrew from the study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University Third Hospital
Investigators
- Study Director: Jie Qiao, Dr, Peking University Third Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M2023460