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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04924309
Enrollment
200
Registered
2021-06-11
Start date
2021-07-05
Completion date
2022-04-20
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Male

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.

Interventions

OTHERExposure: donor sperm

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

Sponsors

Women's Hospital School Of Medicine Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Implantation rate8 monthsImplantation rate is defined as number of sacs per embryo transferred.
clinical pregnancy rate8 monthspresence of at least one gestational sac on ultrasound of 6 weeks

Secondary

MeasureTime frameDescription
Total gonadotropin use8 monthsTotal gonadotropin use of each participant
Ovarian hyperstimulation syndrome (OHSS) rates8 monthsOHSS rates in both study groups
fertilization rate8 monthsNo. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)
Metaphase II (MII) oocytes8 monthsthe number of mature oocytes
Number of oocytes retrieved8 months
cleavage rate8 monthsNo. of cleaved embryo divided by No. of fertilized oocyte

Countries

China

Contacts

Primary ContactYimin Zhu, Dr.
zhuyim@zju.edu.cn057189992071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026