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Clinical Trials/NCT04924309
NCT04924309
Unknown
Not Applicable

Stress in Couples Undergoing Assisted Reproduction Technology With Donor Insemination and Its Impact on Reproductive Outcomes

Women's Hospital School Of Medicine Zhejiang University1 site in 1 country200 target enrollmentJuly 5, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Male
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Enrollment
200
Locations
1
Primary Endpoint
Implantation rate
Last Updated
4 years ago

Overview

Brief Summary

Donor sperm provides a viable option for patients with significant male factor infertility. However, since the source of sperm is not from the male partner, the psychological burden of these couples is more pronounced and complex than other patients.The purpose of this study is to investigate the stress faced by participants undergoing assisted reproduction with donor sperm and to further investigate its impact on pregnancy outcomes.

Detailed Description

The number of infertility patients has increased significantly in recent years, and infertility caused by the male partner accounts for about 30%-50% of infertility factors. Donor sperm provides a viable option for patients with significant male factor infertility. However, since the source of sperm is not from the male partner, the psychological burden of these couples is more pronounced and complex than other patients. Many factors such as social, marital, and family problems may contribute to their depressed emotional state. And the impact of these negative emotions on pregnancy outcomes cannot be ignored. In this study, investigators intend to investigate the stress faced by participants undergoing assisted reproduction with donor sperm 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.

Registry
clinicaltrials.gov
Start Date
July 5, 2021
End Date
April 20, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Female partners' \>18\< 40 years
  • Male partners' \>18\< 40 years
  • Patients undergoing assisted reproductive technology with donor sperm or husband's semen due to male factor

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

Outcomes

Primary Outcomes

Implantation rate

Time Frame: 8 months

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

clinical pregnancy rate

Time Frame: 8 months

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

Secondary Outcomes

  • fertilization rate(8 months)
  • cleavage rate(8 months)
  • Total gonadotropin use(8 months)
  • Metaphase II (MII) oocytes(8 months)
  • Ovarian hyperstimulation syndrome (OHSS) rates(8 months)
  • Number of oocytes retrieved(8 months)

Study Sites (1)

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