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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05055245
• Other study ID #: 20210914
• Status: Not yet recruiting
• Start date: October 9, 2021
• Est. completion date: April 9, 2022

Study information

• Verified date: September 2021
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Yimin Zhu, Dr.
• Phone: 057189992071
• Email: zhuyim[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 9, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
China	Women's Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate	Implantation rate is defined as number of sacs per embryo transferred.	6 months
Primary	clinical pregnancy rate	presence of at least one gestational sac on ultrasound of 6 weeks	6 months
Secondary	fertilization rate	No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)	6 months
Secondary	cleavage rate	No. of cleaved embryo divided by No. of fertilized oocyte	6 months
Secondary	Total gonadotropin use	Total gonadotropin use of each participant	6 months
Secondary	Ovarian hyperstimulation syndrome (OHSS) rates	OHSS rates in both study groups	6 months
Secondary	Number of oocytes retrieved		6 months
Secondary	Metaphase II (MII) oocytes	the number of mature oocytes	6 months