Infertility, FemaleNCT06124950
A Couple-based Gender-transformative Intervention on IPV Against Infertile Women
A study testing Gender-transformative intervention in people with Infertility, Female and Violence, Domestic, run by Peking University Third Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility, Female, Violence, Domestic
- What is being tested?
- Gender-transformative intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 2 sitesChina
- Study dates
- 25 Jun 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Couples who are undergoing their first or second IVF/ICSI cycle;
- Couples diagnosed with female-factor infertility;
- Couples who have signed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Beijing Obstetrics and Gynecology Hospital
Beijing
Xiaokui Yang, Dr, +8613718193183
Ying Fang, Dr, +8613552326071
- Recruiting
Peking University Third Hospital
Beijing
Yu Fu, MS, +8613521777668, annyfy0417@gmail.com
About this study
Official title: A Couple-based Gender-transformative Intervention on Intimate Partner Violence Against Infertile Women
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.
Read the 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).
- Conditions
- Infertility, Female, Violence, Domestic
- Being tested
- Gender-transformative intervention
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gender-transformative interventionBehavioural
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 intervention sessions will be delivered by trained nurses and social workers throughout participants' fertility treatment cycle. Intervention will be carried out at the 5 critical windows of opportunity for infertility treatment: (1) before entering the cycle; (2) during follicular monitoring; (3) before oocyte retrieval; and (4) 2 weeks after the embryo transfer; 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.
| Study group | Role | What they receive |
|---|---|---|
| GTI Intervention | Experimental | Participants in the intervention group will be provided with five GTI sessions (60-minutes/session) by trained nurses and social workers throughout participants' fertility treatment cycle throughout participants' fertility treatment cycle. Receives: Behavioral: Gender-transformative intervention |
| Standard Care | No intervention | Participants in the intervention group will be provided with standard clinical procedures for assisted reproduction and health education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Past-12-months Intimate Partner Violence against infertile women
Past-12-months prevalence of IPV against infertile women measured using an instrument that combined the Revised Conflict Tactics Scale (CTS-2) and the Scale of Economic Abuse-12 (SEA-12).
Respondents will be asked if they had experienced any specific acts of physical (6 items from CTS-2 injury subscale, 12 from CTS-2 physical assault subscale), psychological (8 items from CTS-2 psychological aggression subscale), sexual (7 items from CTS-2 sexual coercion subscale), or economic violence (12 items from SEA-12) in the past 12 months.
The past-12-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 12 months.
Measured: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
Secondary outcomes (22)
Past-12-months Intimate Partner Violence against male partners
Past-12-months prevalence of IPV against male partners measured using an instrument that combined the Revised Conflict Tactics Scale (CTS-2) and the Scale of Economic Abuse-12 (SEA-12).
Respondents will be asked if they had experienced any specific acts of physical (6 items from CTS-2 injury subscale, 12 from CTS-2 physical assault subscale), psychological (8 items from CTS-2 psychological aggression subscale), sexual (7 items from CTS-2 sexual coercion subscale), or economic violence (12 items from SEA-12) in the past 12 months.
The past-12-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 12 months.
Measured: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
Past-3-months Intimate Partner Violence against infertile women
Past-3-months prevalence of IPV against infertile women measured using the World Health Organization Violence Against Women (WHO-VAW) Instrument.
The WHO-VAW has 6 items asking if participants had experienced any specific acts of physical (1 item), sexual (1 item), and psychological (4 items) violence in the past 3 months.
The past-3-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 3 months.
Measured: 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)
Past-3-months Intimate Partner Violence against male partners
Past-3-months prevalence of IPV against male partners measured using the World Health Organization Violence Against Women (WHO-VAW) Instrument.
The WHO-VAW has 6 items asking if participants had experienced any specific acts of physical (1 item), sexual (1 item), and psychological (4 items) violence in the past 3 months.
The past-3-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 3 months.
Measured: 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)
Past-12-months Severe Intimate Partner Violence against infertile women
Past-12-months prevalence of severe IPV against infertile women measured using an instrument that combined the Revised Conflict Tactics Scale (CTS-2) and the Scale of Economic Abuse-12 (SEA-12).
Respondents will be asked if they had experienced any specific acts of physical (6 items from CTS-2 injury subscale, 12 from CTS-2 physical assault subscale), psychological (8 items from CTS-2 psychological aggression subscale), sexual (7 items from CTS-2 sexual coercion subscale), or economic violence (12 items from SEA-12) in the past 12 months.
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.
The past-12-months prevalence of severe IPV is calculated as the proportion of participants reporting at least one severe IPV in the past 12 months.
Measured: T0 (Baseline) and 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 using an instrument that combined the Revised Conflict Tactics Scale (CTS-2) and the Scale of Economic Abuse-12 (SEA-12).
Respondents will be asked if they had experienced any specific acts of physical (6 items from CTS-2 injury subscale, 12 from CTS-2 physical assault subscale), psychological (8 items from CTS-2 psychological aggression subscale), sexual (7 items from CTS-2 sexual coercion subscale), or economic violence (12 items from SEA-12) in the past 12 months.
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.
The past-12-months prevalence of severe IPV is calculated as the proportion of participants reporting at least one severe IPV in the past 12 months.
Measured: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
Attitudes toward male gender roles
Attitudes toward male gender roles measured by the Male Role Attitudes Scale (MRAS) to assess infertile couples' attitudes towards traditional male role stereotypes.
The MRAS has 8 items. Responses to the MRAS were based on a four-point Likert scale from 'strongly disagree=1' to 'strongly agree=4'. A total score was derived by totalling responses to each item, giving a possible score of 8-32, where higher scores indicate greater endorsement of traditional male role stereotypes.
Measured: 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)
Martial quality and satisfaction
Martial quality and satisfaction measured by the Relationship Assessment Scale (RAS).
The RAS has 7 items. Responses to the RAS were based on a five-point Likert scale from 'low=1' to 'high=5'. Items 4 and 7 are reverse-scored. A total score was derived by totalling responses to each item, giving a possible score of 7-35. The higher the score, the more satisfied the respondent is with his/her relationship.
Measured: 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)
Couples' coping with stress
Couples' coping with stress was measured by two items from the Dyadic Coping Inventory (DCI).
Responses to the DCI were based on a five-point Likert scale ranging from 'strongly disagree = 1' to 'strongly agree = 5'.A total score was derived by totalling responses to each item, giving a possible score of 2-10. A higher score indicates couple's better dyadic coping with stress.
Measured: 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)
Patient satisfaction with infertility treatment
Patient satisfaction was measured by one item from the patient satisfaction survey.
Responses to this question were based on a five-point Likert scale ranging from 'strongly disagree = 1' to 'strongly agree = 5'. The score ranged from 1 to 5, with a higher score indicating greater satisfaction with the infertility treatment.
Measured: 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)
Human chorionic gonadotropin (hCG) Positive
Positive for Beta-human chorionic gonadotropin (βhCG) in blood or urine after embryo transfer.
Measured: 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).
Measured: T0 + ~2 months (28-30 days after embryo transfer)
Ongoing pregnancy
Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.
Measured: T0 + ~4 months (12 weeks after embryo transfer)
Miscarriage
Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age.
Measured: 22 weeks of gestation
Biochemical Pregnancy Loss
Positive for hCG after embryo transfer, but no clinical pregnancy observed.
Measured: 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.
Measured: 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).
Measured: After 22 weeks of gestation
Ectopic pregnancy
Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy.
Measured: 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.
Measured: T0 + ~2 months
Preterm birth
Birth of a fetus delivered after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy.
Measured: 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.
Measured: 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.
Measured: Within 2 weeks after live birth
Neonatal mortality
Death of a live born baby within 28 days of birth
Measured: Within 28 days of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start25 Jun 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 752 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital
- Responsible party
- Principal investigator, Jie Qiao, Peking University Third Hospital
- Investigators
- Jie Qiao, Dr, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124950
- Sponsor's protocol ID
- M2023460
- Status last verified
- Aug 2024
- First submitted
- 20 Oct 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the nature of the study, individual participant data (IPD) will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Couple-based Gender-transformative Intervention on Intimate Partner Violence Against Infertile Women
- ClinicalTrials.gov ID
- NCT06124950
- Acronym / sponsor ID
- M2023460
- Conditions
- Infertility, Female, Violence, Domestic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 752 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GTI Intervention | Experimental | Behavioral: Gender-transformative interventionParticipants in the intervention group will be provided with five GTI sessions (60-minutes/session) by trained nurses and social workers throughout participants' fertility treatment cycle throughout participants' fertility treatment cycle. |
| Standard Care | No intervention | –Participants in the intervention group will be provided with standard clinical procedures for assisted reproduction and health education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Couples who are undergoing their first or second IVF/ICSI cycle;
- Couples diagnosed with female-factor infertility;
- Couples who have signed consent.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gender-transformative interventionA 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 intervention sessions will be delivered by trained nurses and social workers throughout participants' fertility treatment cycle. Intervention will be carried out at the 5 critical windows of opportunity for infertility treatment: (1) before entering the cycle; (2) during follicular monitoring; (3) before oocyte retrieval; and (4) 2 weeks after the embryo transfer; 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. | Behavioural | GTI Intervention |
Primary outcome
Past-12-months Intimate Partner Violence against infertile women
Time frame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
Past-12-months prevalence of IPV against infertile women measured using an instrument that combined the Revised Conflict Tactics Scale (CTS-2) and the Scale of Economic Abuse-12 (SEA-12). Respondents will be asked if they had experienced any specific acts of physical (6 items from CTS-2 injury subscale, 12 from CTS-2 physical assault subscale), psychological (8 items from CTS-2 psychological aggression subscale), sexual (7 items from CTS-2 sexual coercion subscale), or economic violence (12 items from SEA-12) in the past 12 months. The past-12-months prevalence of IPV is calculated as the proportion of participants reporting at least one act of violence in the past 12 months.
22 secondary outcomes
Past-12-months Intimate Partner Violence against male partners
Time frame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
Past-3-months Intimate Partner Violence against infertile women
Time frame: 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)
Past-3-months Intimate Partner Violence against male partners
Time frame: 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)
Past-12-months Severe Intimate Partner Violence against infertile women
Time frame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
Past-12-months severe Intimate Partner Violence against male partners
Time frame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)
Attitudes toward male gender roles
Time frame: 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)
Martial quality and satisfaction
Time frame: 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)
Couples' coping with stress
Time frame: 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)
Patient satisfaction with infertility treatment
Time frame: 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)
Human chorionic gonadotropin (hCG) Positive
Time frame: T0 + ~1.5 months
Clinical pregnancy
Time frame: T0 + ~2 months (28-30 days after embryo transfer)
Ongoing pregnancy
Time frame: T0 + ~4 months (12 weeks after embryo transfer)
Miscarriage
Time frame: 22 weeks of gestation
Biochemical Pregnancy Loss
Time frame: T0 + 1.5-2 months
Stillbirth
Time frame: After 22 weeks of gestation
Live birth
Time frame: After 22 weeks of gestation
Ectopic pregnancy
Time frame: 7 weeks of gestation
Cycle cancellation
Time frame: T0 + ~2 months
Preterm birth
Time frame: 28-37 weeks of pregnancy
Birth weight
Time frame: Within the first hour after live birth
Congenital anomaly
Time frame: Within 2 weeks after live birth
Neonatal mortality
Time frame: Within 28 days of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No. Given the nature of the study, individual participant data (IPD) will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Qiao, Dr principal investigator
Peking University Third Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gender-transformative intervention in people with Infertility, Female and Violence, Domestic, run by Peking University Third Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Fu, MS (+86 13521777668, annyfy0417@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Past-12-months Intimate Partner Violence against infertile women (time frame: T0 (Baseline) and T0 + ~14 months (4 weeks after delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.