Stress in Couples Undergoing Assisted Reproduction Technology With Donor Sperm and Its Impact on Pregnancy Outcomes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility, Male
• Intervention / Treatment: Other: Exposure: donor sperm

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.

• 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
      • Recruiting
      • Women's Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing assisted reproductive technology with donor sperm or husband's semen due to male factor

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing assisted reproductive technology with donor sperm	Other: Exposure: donor sperm; One group use donor sperm through the process of assisted reproduction and the other uses husband's semen.
Patients undergoing assisted reproductive technology with husband's semen due to male factor

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.	8 months
clinical pregnancy rate	presence of at least one gestational sac on ultrasound of 6 weeks	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fertilization rate	No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)	8 months
cleavage rate	No. of cleaved embryo divided by No. of fertilized oocyte	8 months
Total gonadotropin use	Total gonadotropin use of each participant	8 months
Ovarian hyperstimulation syndrome (OHSS) rates	OHSS rates in both study groups	8 months
Number of oocytes retrieved		8 months
Metaphase II (MII) oocytes	the number of mature oocytes	8 months

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Anticipated): March 20, 2022
• Study Completion (Anticipated): April 20, 2022

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: 20210328

Drug and device information, study documents

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