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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility
• Intervention / Treatment: Other: cycles

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Yimin Zhu, Dr.; Phone Number: 057189992071; Email: zhuyim@zju.edu.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing assisted reproductive technology

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing assisted reproductive technology; Patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)	Other: cycles; Patients are grouped according to the number of IVF/ICSI cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oocytes retrieved		6 months
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	6 months
Total gonadotropin use	Total gonadotropin use of each participant	6 months
Ovarian hyperstimulation syndrome (OHSS) rates	OHSS rates in both study groups	6 months
Metaphase II (MII) oocytes	the number of mature oocytes	6 months

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Investigators: Study Chair: Yimin Zhu, Dr., Women's Hospital School of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 9, 2021
• Primary Completion (Anticipated): March 9, 2022
• Study Completion (Anticipated): April 9, 2022

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: infertility; cycle
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 20210914

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No