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

• Conditions: Infertility, Male

• Registration Number: NCT04924309
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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.

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-11
• Study Start: 2021-07-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16
• Primary Completion: 2022-03-20
• Study Completion: 2022-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implantation rate	8 months	Implantation rate is defined as number of sacs per embryo transferred.
clinical pregnancy rate	8 months	presence of at least one gestational sac on ultrasound of 6 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Women's Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China