NCT05055245

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

October 9, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2022

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

September 14, 2021

Last Update Submit

September 14, 2021

Conditions

Keywords

infertilitycycle

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)

Other: cycles

Interventions

cyclesOTHER

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

Patients undergoing assisted reproductive technology

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Yimin Zhu, Dr.

    Women's Hospital School Of Medicine Zhejiang University

    STUDY CHAIR

Central Study Contacts

Yimin Zhu, Dr.

CONTACT

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

Locations