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Status unknownNCT05055245Updated Sep 24, 2021

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

An observational study in Infertility, sponsored by Women's Hospital School Of Medicine Zhejiang University. Status unknown at 1 site in China. Open to participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-09-24.

Sponsored by Women's Hospital School Of Medicine Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
16 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility

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Keywords

  • infertility
  • cycle
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing assisted reproductive technology

Inclusion criteria

  • Female partners' >18\< 40 years
  • Patients undergoing assisted reproductive technology

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients undergoing assisted reproductive technology

    Patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)

    Other: cycles

Interventions

  • Othercycles

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

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What researchers measure

Primary outcomes

  1. Implantation rate

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

    Time frame: 6 months

  2. clinical pregnancy rate

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

    Time frame: 6 months

Secondary outcomes

  1. fertilization rate

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

    Time frame: 6 months

  2. cleavage rate

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

    Time frame: 6 months

  3. Total gonadotropin use

    Total gonadotropin use of each participant

    Time frame: 6 months

  4. Ovarian hyperstimulation syndrome (OHSS) rates

    OHSS rates in both study groups

    Time frame: 6 months

  5. Number of oocytes retrieved

    Time frame: 6 months

  6. Metaphase II (MII) oocytes

    the number of mature oocytes

    Time frame: 6 months

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Study locations

1 site
  • Women's Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05055245
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Responsible party
Yimin Zhu (Chief Physician, Women's Hospital School Of Medicine Zhejiang University) — Principal investigator
First posted
Sep 24, 2021
Start date
Oct 9, 2021 (estimated)
Primary completion
Mar 9, 2022 (estimated)
Completion
Apr 9, 2022 (estimated)
Last update
Sep 24, 2021

Study contacts

Yimin Zhu, Dr.
Contact
zhuyim@zju.edu.cn
057189992071
Yimin Zhu, Dr.
study chair · Women's Hospital School Of Medicine Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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