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

Conditions
Infertility
Interventions
Other: cycles
Registration Number
NCT05055245
Lead Sponsor
Women's Hospital School Of Medicine Zhejiang University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients undergoing assisted reproductive technologycyclesPatients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
Primary Outcome Measures
NameTimeMethod
clinical pregnancy rate6 months

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

Implantation rate6 months

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

Secondary Outcome Measures
NameTimeMethod
Metaphase II (MII) oocytes6 months

the number of mature oocytes

Total gonadotropin use6 months

Total gonadotropin use of each participant

Ovarian hyperstimulation syndrome (OHSS) rates6 months

OHSS rates in both study groups

fertilization rate6 months

No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)

cleavage rate6 months

No. of cleaved embryo divided by No. of fertilized oocyte

Number of oocytes retrieved6 months

Trial Locations

Locations (1)

Women's Hospital, School of Medicine, Zhejiang University

🇨🇳

Hangzhou, Zhejiang, China

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