Stress in Couples Undergoing Assisted Reproduction Technology With Different Cycles and Its Impact on Pregnancy Outcomes

NCT ID: NCT05055245

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-09
• Study Completion Date: 2022-04-09

Brief Summary

With the development of assisted reproductive technology (ART), more and more infertile women are obtaining their offspring through assisted reproductive technology. However, a growing number of national and international studies have shown that infertility patients are prone to negative emotions such as anxiety and depression during ART treatment, which not only affects their physical and mental health, but also affects the embryo implantation rate and pregnancy rate of ART. The purpose of this study is to investigate the stress faced by participants undergoing ART with different cycles and to further investigate its impact on pregnancy outcomes.

Detailed Description

With the rapid social and economic development in recent years, the incidence of infertility has increased significantly due to environmental pollution, poor lifestyle habits and increasing stress in various areas. According to global statistics, one in six married couples suffers from infertility. With the development of assisted reproductive technology (ART), more and more infertile women are obtaining their offspring. In clinical practice, however, a significant proportion of patients undergoing ART have low embryo implantation and pregnancy rates and experience recurrent implantation failure (RIF). A growing number of national and international studies have shown that infertility patients are prone to negative emotions such as anxiety and depression during ART treatment, which not only affects their physical and mental health, but also affects the embryo implantation rate and pregnancy rate of ART. This effect is more pronounced in patients with multiple failed transfers. In this study, investigators intend to investigate the stress faced by participants undergoing assisted reproduction with different cycles to provide a reliable basis for future psychological interventions and health education for this group of patients and improve the quality of life of infertility patients.

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing assisted reproductive technology

Patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)

cycles

Intervention Type: OTHER

Patients are grouped according to the number of IVF/ICSI cycles.

Interventions

cycles

Patients are grouped according to the number of IVF/ICSI cycles.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female partners' >18< 40 years
• Patients undergoing assisted reproductive technology

Exclusion Criteria

• Female partners with polycystic ovary
• Female partners with insufficiency or premature ovarian failure
• Female partners with endometriosis
• Female partners with abnormal profile of thyroid hormones
• Chromosomal abnormalities of either spouse
• Mental disorder of either spouse

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Yimin Zhu

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yimin Zhu, Dr.

Role: STUDY_CHAIR

Women's Hospital School Of Medicine Zhejiang University

Locations

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Yimin Zhu, Dr.

Role: CONTACT

zhuyim@zju.edu.cn

057189992071

Facility Contacts

Yimin Zhu

Role: primary

zhuyim@zju.edu.cn

057189992071

Other Identifiers

20210914

Identifier Type: -

Identifier Source: org_study_id