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

Sponsor
Women's Hospital School Of Medicine Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04924309
Collaborator
(none)
200
1
9.5
21.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exposure: donor sperm

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Stress in Couples Undergoing Assisted Reproduction Technology With Donor Insemination and Its Impact on Reproductive Outcomes
Actual Study Start Date :
Jul 5, 2021
Anticipated Primary Completion Date :
Mar 20, 2022
Anticipated Study Completion Date :
Apr 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing assisted reproductive technology with donor sperm

Other: Exposure: donor sperm
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

Outcome Measures

Primary Outcome Measures

  1. Implantation rate [8 months]

    Implantation rate is defined as number of sacs per embryo transferred.

  2. clinical pregnancy rate [8 months]

    presence of at least one gestational sac on ultrasound of 6 weeks

Secondary Outcome Measures

  1. fertilization rate [8 months]

    No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)

  2. cleavage rate [8 months]

    No. of cleaved embryo divided by No. of fertilized oocyte

  3. Total gonadotropin use [8 months]

    Total gonadotropin use of each participant

  4. Ovarian hyperstimulation syndrome (OHSS) rates [8 months]

    OHSS rates in both study groups

  5. Number of oocytes retrieved [8 months]

  6. Metaphase II (MII) oocytes [8 months]

    the number of mature oocytes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women's Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China

Sponsors and Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

Investigators

  • Study Chair: Yimin Zhu, Women's Hospital School Of Medicine Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier:
NCT04924309
Other Study ID Numbers:
  • 20210328
First Posted:
Jun 11, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021