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

NCT ID: NCT04924309

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-05

Study Completion Date

2022-04-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility, Male

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing assisted reproductive technology with donor sperm

Exposure: donor sperm

Intervention Type OTHER

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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exposure: donor sperm

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yimin Zhu

Role: STUDY_CHAIR

Women's Hospital School Of Medicine Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yimin Zhu, Dr.

Role: CONTACT

057189992071

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yimin Zhu

Role: primary

057189992071

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20210328

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.