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

Infertility, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924309
• Other study ID #: 20210328
• Status: Recruiting
• Start date: July 5, 2021
• Est. completion date: April 20, 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 [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 20, 2022
• Est. primary completion date: March 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Other:
• Exposure: donor sperm
One group use donor sperm through the process of assisted reproduction and the other uses husband's semen.

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.	8 months
Primary	clinical pregnancy rate	presence of at least one gestational sac on ultrasound of 6 weeks	8 months
Secondary	fertilization rate	No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)	8 months
Secondary	cleavage rate	No. of cleaved embryo divided by No. of fertilized oocyte	8 months
Secondary	Total gonadotropin use	Total gonadotropin use of each participant	8 months
Secondary	Ovarian hyperstimulation syndrome (OHSS) rates	OHSS rates in both study groups	8 months
Secondary	Number of oocytes retrieved		8 months
Secondary	Metaphase II (MII) oocytes	the number of mature oocytes	8 months