NCT06124950 A Couple-based Gender-transformative Intervention on IPV Against Infertile Women
| NCT ID | NCT06124950 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | Infertility, Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 752 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 752 participants in total. It began in 2024-06-25 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jie Qiao, Dr
PRINCIPAL INVESTIGATOR
Peking University Third Hospital
Frequently Asked Questions
Who can join the NCT06124950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infertility, Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06124950 currently recruiting?
Yes, NCT06124950 is actively recruiting participants. Contact the research team at annyfy0417@gmail.com for enrollment information.
Where is the NCT06124950 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT06124950 clinical trial?
NCT06124950 is sponsored by Peking University Third Hospital. The principal investigator is Jie Qiao, Dr at Peking University Third Hospital. The trial plans to enroll 752 participants.