Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06124950 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusUnknown
PhaseNot applicable
Started2024-06-25
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 28, 2024 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
Trial status changed: Recruiting → Unknown
2024-08-26
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v3
Trial statusNot Yet Recruiting→Unknown
Primary completion date2025-07→2026-07
Completion date2026-02→2026-07
Start dateestimated 2024-05→confirmed 2024-06-25
Enrollment target480→752
Study sites0→2
Eligibility criteria-18 characters
Inclusion Criteria: Couples who are undergoing their first or second IVF-ET/ICSI cycle; Couples who are receiving a fresh embryo; Couples with primary infertility; Couplesdiagnosed 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 changehave fromnot aundergone freshembryo cycletransfer towithin asix freeze-thawmonths cycleafter oocyte retrieval; [...] [...]
Secondary endpoints19 to 22 entries
Past-3-months Intimate Partner Violence against infertile women Past-3-months Intimate Partner Violence against male partners Couples' coping with stress and patient Patient satisfaction with infertility treatment
Study description+1,994 characters
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 int [...]
Collaborators+42 characters
Beijing Obstetrics and Gynecology Hospital
2024-05-17
Study Status v2
Start date2024-02→2024-05
2023-12-22
Study Status, Outcome Measures v1
Primary completion date2025-05→2025-07
Completion date2025-11→2026-02
Start date2023-11→2024-02
Secondary endpoints17 to 19 entries
Past-12-months Intimate Partner Violence against male partners Past-12-months Severe Intimate Partner Violence against infertile women Past-12-months severe Intimate Partner Violence against male partners
Primary endpoints1 entry, revised
Past-12-months Intimate Partner Violence against infertile women
2023-11-06
Original filing
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.
Trial Details
NCT Number NCT06124950
Lead Sponsor Peking University Third Hospital
Collaborators: Beijing Obstetrics and Gynecology Hospital
Conditions Infertility, Female, Violence, Domestic
Enrollment 752 participants
Start Date 2024-06-25
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2024-08-28