Stress in Couples Undergoing Assisted Reproduction Technology With Different Cycles and Its Impact on Pregnancy Outcomes
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedStudy Start
First participant enrolled
October 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2022
CompletedSeptember 24, 2021
September 1, 2021
5 months
September 14, 2021
September 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Implantation rate
Implantation rate is defined as number of sacs per embryo transferred.
6 months
clinical pregnancy rate
presence of at least one gestational sac on ultrasound of 6 weeks
6 months
Secondary Outcomes (6)
fertilization rate
6 months
cleavage rate
6 months
Total gonadotropin use
6 months
Ovarian hyperstimulation syndrome (OHSS) rates
6 months
Number of oocytes retrieved
6 months
- +1 more secondary outcomes
Study Arms (1)
Patients undergoing assisted reproductive technology
Patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
Interventions
Patients are grouped according to the number of IVF/ICSI cycles.
Eligibility Criteria
Patients undergoing assisted reproductive technology
You may qualify if:
- Female partners' \>18\< 40 years
- Patients undergoing assisted reproductive technology
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yimin Zhu, Dr.
Women's Hospital School Of Medicine Zhejiang University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
September 14, 2021
First Posted
September 24, 2021
Study Start
October 9, 2021
Primary Completion
March 9, 2022
Study Completion
April 9, 2022
Last Updated
September 24, 2021
Record last verified: 2021-09