Infertility, Female Clinical Trial
Official title:
A Couple-based Gender-transformative Intervention on Intimate Partner Violence Against Infertile Women
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05969574 -
Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
|
||
Recruiting |
NCT05358483 -
PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
|
||
Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
Completed |
NCT03177538 -
Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders
|
Phase 4 | |
Completed |
NCT03638856 -
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
|
N/A | |
Completed |
NCT04052464 -
The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
|
||
Withdrawn |
NCT04753736 -
Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC
|
N/A | |
Completed |
NCT03349905 -
Deferred Versus Fresh Embryo Transfers
|
N/A | |
Completed |
NCT05076981 -
Progesterone Levels During Ovulation and Luteal Phase
|
||
Completed |
NCT04096027 -
Cabergoline Before or After Oocyte Collection for Follicular Resolution
|
Phase 4 | |
Recruiting |
NCT05980091 -
Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.
|
Phase 1 | |
Terminated |
NCT01933633 -
Improved Fertility After Exercise in Overweight/Obese Women
|
N/A | |
Terminated |
NCT01202643 -
Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF
|
Phase 1/Phase 2 | |
Completed |
NCT01202656 -
Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
|
Phase 1/Phase 2 | |
Completed |
NCT01408615 -
A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
|
||
Enrolling by invitation |
NCT05698550 -
The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET
|
Phase 3 | |
Not yet recruiting |
NCT03910582 -
Personalized FET in RIF Patients With Displaced Dating
|
N/A | |
Completed |
NCT05440019 -
Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
|
||
Completed |
NCT05130125 -
Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer
|