Clinical trial NCT04924309: Stress in Couples Undergoing Assisted Reproduction Technology With Donor Sperm and Its Impact on Pregnancy Outcomes
Official title: Stress in Couples Undergoing Assisted Reproduction Technology With Donor Insemination and Its Impact on Reproductive Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Male
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing assisted reproductive technology with donor sperm or husband's semen due to male factor

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implantation rate
timeFrame: 8 months
measure: clinical pregnancy rate
timeFrame: 8 months
Secondary outcomes:
measure: fertilization rate
timeFrame: 8 months
measure: cleavage rate
timeFrame: 8 months
measure: Total gonadotropin use
timeFrame: 8 months
measure: Ovarian hyperstimulation syndrome (OHSS) rates
timeFrame: 8 months
measure: Number of oocytes retrieved
timeFrame: 8 months
measure: Metaphase II (MII) oocytes
timeFrame: 8 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Yimin Zhu
role: STUDY_CHAIR
References: