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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06124950
Other study ID # M2023460
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date February 2026

Study information

Verified date September 2023
Source Peking University Third Hospital
Contact Yu Fu
Phone +86 13521777668
Email annyfy0417@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 480
Est. completion date February 2026
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Couples who are undergoing their first or second IVF-ET cycle; - Couples who are receiving a fresh embryo; - Couples with primary infertility; - Couples with female-factor infertility; - Couples who have signed consent Exclusion Criteria: - Couples who receive donated oocytes, sperm, or embryos; - Couples with male-factor infertility or unexplained infertility; - Couples who are undergoing Preimplantation Genetic Testing (PGT); - Couples who change from a fresh cycle to a freeze-thaw cycle; - Couples who have severe mental disorders; - Couples who withdrew from the study

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Past-12-months Intimate Partner Violence against infertile women Past-12-months prevalence of past-12-months IPV against infertile women measured by a standardized instrument 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)
Secondary Past-12-months Intimate Partner Violence against male partners Past-12-months prevalence of IPV against male partners measured by a standardized instrument 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)
Secondary Past-12-months Severe Intimate Partner Violence against infertile women Past-12-months prevalence of severe IPV against infertile women measured by a standardized instrument; 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. 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)
Secondary Past-12-months severe Intimate Partner Violence against male partners Past-12-months prevalence of severe IPV against male partners measured by a standardized instrument; 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. 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)
Secondary Attitudes toward male gender roles Measured by the "Male Role Attitudes Scale (MRAS)" to assess infertile couples' attitudes towards traditional male role stereotypes 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)
Secondary Martial quality and satisfaction Measured by the "Relationship Assessment Scale (RAS)" 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)
Secondary Couples' coping with stress and patient satisfaction Measured by two items from the "Dyadic Coping Inventory (DCI)" and one item from the patient satisfaction survey 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)
Secondary Human chorionic gonadotropin (hCG) Positive Positive for Beta-human chorionic gonadotropin (ßhCG) in blood or urine after embryo transfer T0 + ~1.5 months
Secondary 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) T0 + ~2 months (28-30 days after embryo transfer)
Secondary Ongoing pregnancy Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation T0 + ~4 months (12 weeks after embryo transfer)
Secondary Miscarriage Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age 22 weeks of gestation
Secondary Biochemical Pregnancy Loss Positive for hCG after embryo transfer, but no clinical pregnancy observed T0 + 1.5-2 months
Secondary Stillbirth Fetal death after 22 weeks of gestation, with no signs of life such as heartbeat, breathing, umbilical cord pulse, or voluntary muscle contraction After 22 weeks of gestation
Secondary Live birth A delivery of one or more living infants (=22 weeks gestation or birth weight more than 1,000g) After 22 weeks of gestation
Secondary Ectopic pregnancy Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy 7 weeks of gestation
Secondary 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.
T0 + ~1 months
Secondary Preterm birth Birth of a fetus delivered after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy 28-37 weeks of pregnancy
Secondary Birth weight The weight measured for the first time within the first hour after birth. High birth weight: =4kg; Low birth weight: < 2.5kg Within the first hour after live birth
Secondary 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. Within 2 weeks after live birth
Secondary Neonatal mortality Death of a live born baby within 28 days of birth Within 28 days of birth
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