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Clinical Trials/NCT05055245
NCT05055245
Unknown
Not Applicable

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

Women's Hospital School Of Medicine Zhejiang University1 site in 1 country200 target enrollmentOctober 9, 2021
ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Enrollment
200
Locations
1
Primary Endpoint
clinical pregnancy rate
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 9, 2021
End Date
April 9, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yimin Zhu

Chief Physician

Women's Hospital School Of Medicine Zhejiang University

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

Outcomes

Primary Outcomes

clinical pregnancy rate

Time Frame: 6 months

presence of at least one gestational sac on ultrasound of 6 weeks

Implantation rate

Time Frame: 6 months

Implantation rate is defined as number of sacs per embryo transferred.

Secondary Outcomes

  • Metaphase II (MII) oocytes(6 months)
  • Total gonadotropin use(6 months)
  • Ovarian hyperstimulation syndrome (OHSS) rates(6 months)
  • fertilization rate(6 months)
  • cleavage rate(6 months)
  • Number of oocytes retrieved(6 months)

Study Sites (1)

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