Stress in Couples Undergoing Assisted Reproduction Technology With Donor Sperm and Its Impact on Pregnancy Outcomes
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2021
CompletedFirst Posted
Study publicly available on registry
June 11, 2021
CompletedStudy Start
First participant enrolled
July 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2022
CompletedSeptember 16, 2021
September 1, 2021
9 months
June 7, 2021
September 14, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
fertilization rate
8 months
cleavage rate
8 months
Total gonadotropin use
8 months
Ovarian hyperstimulation syndrome (OHSS) rates
8 months
Number of oocytes retrieved
8 months
- +1 more secondary outcomes
Study Arms (2)
Patients undergoing assisted reproductive technology with donor sperm
Patients undergoing assisted reproductive technology with husband's semen due to male factor
Interventions
One group use donor sperm through the process of assisted reproduction and the other uses husband's semen.
Eligibility Criteria
Patients undergoing assisted reproductive technology with donor sperm or husband's semen due to male factor
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yimin Zhu
Women's Hospital School Of Medicine Zhejiang University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2021
First Posted
June 11, 2021
Study Start
July 5, 2021
Primary Completion
March 20, 2022
Study Completion
April 20, 2022
Last Updated
September 16, 2021
Record last verified: 2021-09