Infertility, MaleNCT04924309
Stress in Couples Undergoing Assisted Reproduction Technology With Donor Sperm and Its Impact on Pregnancy Outcomes
An observational study of Infertility, Male, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Exposure: donor sperm
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2021to 20 Apr 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing assisted reproductive technology with donor sperm or husband's semen due to male factor
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Yimin Zhu, 057189992071, zhuyim@zju.edu.cn
About this study
Official title: Stress in Couples Undergoing Assisted Reproduction Technology With Donor Insemination and Its Impact on Reproductive Outcomes
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.
Read the 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.
- Conditions
- Infertility, Male
- Being tested
- Exposure: donor sperm
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: donor spermOther
One group use donor sperm through the process of assisted reproduction and the other uses husband's semen.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing assisted reproductive technology with donor sperm | Not described Receives: Other: Exposure: donor sperm | |
| Patients undergoing assisted reproductive technology with husband's semen due to male factor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Implantation rate is defined as number of sacs per embryo transferred.
Measured: 8 months
clinical pregnancy rate
presence of at least one gestational sac on ultrasound of 6 weeks
Measured: 8 months
Secondary outcomes (6)
fertilization rate
No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)
Measured: 8 months
cleavage rate
No. of cleaved embryo divided by No. of fertilized oocyte
Measured: 8 months
Total gonadotropin use
Total gonadotropin use of each participant
Measured: 8 months
Ovarian hyperstimulation syndrome (OHSS) rates
OHSS rates in both study groups
Measured: 8 months
Number of oocytes retrieved
Measured: 8 months
Metaphase II (MII) oocytes
the number of mature oocytes
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start5 Jul 2021
- Primary completion20 Mar 2022 (estimated)
- Study completion20 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yimin Zhu, Study chair, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924309
- Sponsor's protocol ID
- 20210328
- Status last verified
- Sep 2021
- First submitted
- 7 Jun 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress in Couples Undergoing Assisted Reproduction Technology With Donor Insemination and Its Impact on Reproductive Outcomes
- ClinicalTrials.gov ID
- NCT04924309
- Acronym / sponsor ID
- 20210328
- Conditions
- Infertility, Male
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 20 Apr 2022 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing assisted reproductive technology with donor sperm | – | Other: Exposure: donor sperm |
| Patients undergoing assisted reproductive technology with husband's semen due to male factor | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing assisted reproductive technology with donor sperm or husband's semen due to male factor
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure: donor spermOne group use donor sperm through the process of assisted reproduction and the other uses husband's semen. | Other | Patients undergoing assisted reproductive technology with donor sperm |
Primary outcome
Implantation rate
Time frame: 8 months
Implantation rate is defined as number of sacs per embryo transferred.
clinical pregnancy rate
Time frame: 8 months
presence of at least one gestational sac on ultrasound of 6 weeks
6 secondary outcomes
fertilization rate
Time frame: 8 months
cleavage rate
Time frame: 8 months
Total gonadotropin use
Time frame: 8 months
Ovarian hyperstimulation syndrome (OHSS) rates
Time frame: 8 months
Number of oocytes retrieved
Time frame: 8 months
Metaphase II (MII) oocytes
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Related trials for Infertility, Male
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yimin Zhu study chair
Women's Hospital School Of Medicine Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Male, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yimin Zhu, Dr. (057189992071, zhuyim@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.