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

Study Overview
=================
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.

Official Title
-----------------
Stress in Couples Undergoing Assisted Reproduction Technology With Donor Insemination and Its Impact on Reproductive Outcomes

Conditions
-----------------
Infertility, Male

Intervention / Treatment
-----------------
* Other: Exposure: donor sperm


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing assisted reproductive technology with donor sperm<br> | Other: Exposure: donor sperm<br>* One group use donor sperm through the process of assisted reproduction and the other uses husband's semen.<br>|
| Patients undergoing assisted reproductive technology with husband's semen due to male factor<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fertilization rate | No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs) | 8 months | 
| cleavage rate | No. of cleaved embryo divided by No. of fertilized oocyte | 8 months | 
| Total gonadotropin use | Total gonadotropin use of each participant | 8 months | 
| Ovarian hyperstimulation syndrome (OHSS) rates | OHSS rates in both study groups | 8 months | 
| Number of oocytes retrieved |  | 8 months | 
| Metaphase II (MII) oocytes | the number of mature oocytes | 8 months |