Stress in Couples Undergoing Assisted Reproduction Techno... | NCT05055245

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

NCT05055245

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Status

Unknown status

Last Update Posted

Sep 24, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Infertility

Interventions

cycles

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 9, 2021Estimated

Primary Completion Date

Mar 9, 2022Estimated

Completion Date

Apr 9, 2022Estimated

First Submitted Date

Sep 14, 2021

First Submission Date that Met QC Criteria

Sep 14, 2021

First Posted Date

Sep 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2021

Last Update Posted Date

Sep 24, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yimin Zhu, Chief Physician, Women's Hospital School Of Medicine Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Women's Hospital School Of Medicine Zhejiang UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing assisted reproductive technology		Patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)	Other: cycles

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cycles	Other	Patients are grouped according to the number of IVF/ICSI cycles.	Patients undergoing assisted reproductive technology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
fertilization rate	No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)	6 months
cleavage rate	No. of cleaved embryo divided by No. of fertilized oocyte

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Patients undergoing assisted reproductive technology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yimin Zhu, Dr.	Contact	057189992071		zhuyim@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Yimin Zhu, Dr.	Women's Hospital School Of Medicine Zhejiang University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's Hospital, School of Medicine, Zhejiang University		Hangzhou	Zhejiang		China

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

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