Clinical trial NCT06124950: A Couple-based Gender-transformative Intervention on IPV Against Infertile Women
Official title: A Couple-based Gender-transformative Intervention on Intimate Partner Violence Against Infertile Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility, Female
Violence, Domestic
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Obstetrics and Gynecology Hospital
First posted: 2023-11-09
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Past-12-months Intimate Partner Violence against infertile women
timeFrame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
Secondary outcomes:
measure: Past-12-months Intimate Partner Violence against male partners
timeFrame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
measure: Past-3-months Intimate Partner Violence against infertile women
timeFrame: 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)
measure: Past-3-months Intimate Partner Violence against male partners
timeFrame: 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)
measure: Past-12-months Severe Intimate Partner Violence against infertile women
timeFrame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
measure: Past-12-months severe Intimate Partner Violence against male partners
timeFrame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
measure: Attitudes toward male gender roles
timeFrame: 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)
measure: Martial quality and satisfaction
timeFrame: 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)
measure: Couples' coping with stress
timeFrame: 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)
measure: Patient satisfaction with infertility treatment
timeFrame: 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)
measure: Human chorionic gonadotropin (hCG) Positive
timeFrame: T0 + ~1.5 months
measure: Clinical pregnancy
timeFrame: T0 + ~2 months (28-30 days after embryo transfer)
measure: Ongoing pregnancy
timeFrame: T0 + ~4 months (12 weeks after embryo transfer)
measure: Miscarriage
timeFrame: 22 weeks of gestation
measure: Biochemical Pregnancy Loss
timeFrame: T0 + 1.5-2 months
measure: Stillbirth
timeFrame: After 22 weeks of gestation
measure: Live birth
timeFrame: After 22 weeks of gestation
measure: Ectopic pregnancy
timeFrame: 7 weeks of gestation
measure: Cycle cancellation
timeFrame: T0 + ~2 months
measure: Preterm birth
timeFrame: 28-37 weeks of pregnancy
measure: Birth weight
timeFrame: Within the first hour after live birth
measure: Congenital anomaly
timeFrame: Within 2 weeks after live birth
measure: Neonatal mortality
timeFrame: Within 28 days of birth
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Jie Qiao, Dr
role: PRINCIPAL_INVESTIGATOR
References: