Sperm Count, LowNCT03594201
A Retrospective Study on the Effect of Male Progressive Sperm Count After Semen Pretreatment on ICSI Fertilization Outcome
An observational study of Sperm Count, Low and Reproductive Sterility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial summary
The investigators plan to retrospectively analyze clinical data from 14,189 fresh ICSI cycles in Reproductive and Genetic Hospital of CITIC-Xiangya from January 2016 to December 2017.The investigators will regard total progressive sperm number of 2 x 10^6 after pretreatment as the boundary value, and will divide total… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sperm Count, Low, Reproductive Sterility
- What is being tested?
- semen pretreatment
- How many people
- 12,215 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 3 Jan 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infertile couples take ART treament due to poor male semen quality.
Who may be able to join
- infertility female and sterility male for reproductive treatment
Who cannot join
- chromosomal abnormalities
- none retrieval oocyte
- none oocyte for ICSI
- Recurrent abortion
- female age≥37 years
- Assisted hatching
Show all 9Show fewer
- abnormal oocyte zona pellucida
- In Vitro Maturation
- AZF microdeletion
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410008
About this study
The investigators plan to retrospectively analyze clinical data from 14,189 fresh ICSI cycles in Reproductive and Genetic Hospital of CITIC-Xiangya from January 2016 to December 2017.The investigators will regard total progressive sperm number of 2 x 10^6 after pretreatment as the boundary value, and will divide total progressive sperm number of 2 x 10^6 after pretreatment into 2 x 10^6 or higher and < 2 x 10^6 groups, and will further divide < 2 x 10^6 group into: = 0, (0,10^6], (10^6, 2 x 10^6) three groups. Propensity score matching will be used to balance the baseline data between four groups. The matching variables are age, female BMI, AFC, AMH and ICSI.
- Conditions
- Sperm Count, Low, Reproductive Sterility
- Being tested
- semen pretreatment
- Keywords
- ICSI, progressive sperm count, embryo
- Medical subject headings
- Oligospermia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semen pretreatmentOther
semen pretreatment
| Study group | Role | What they receive |
|---|---|---|
| group1 | A+B grade sperm count after treatment=0 Receives: Other: semen pretreatment | |
| group2 | 0<A+B grade sperm count after treatment≤10^6 Receives: Other: semen pretreatment | |
| group3 | 10^6<A+B grade sperm count after treatment<2*10^6 Receives: Other: semen pretreatment | |
| group4 | A+B grade sperm count after treatment≥2*10^6 Receives: Other: semen pretreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
high quality embryo rate for ICSI
rate of embryo grade above 6CI on the third day after fertilization
Measured: two years
Secondary outcomes (2)
fertilization rate of ICSI
number of fertilized oocytes/ number of metaphase II oocytes
Measured: two years
normal fertilization rate of ICSI
number of 2PN fertilized oocytes/ number of metaphase II oocytes
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion3 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm Count, LowStudies 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
- Retrospective
- Enrolment
- 12,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liang Hu, MD,PHD, Principal investigator, Reproductive & Genetic Hospital of CITIC-Xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594201
- Sponsor's protocol ID
- KYXM-201803
- Status last verified
- Jul 2018
- First submitted
- 11 Jul 2018
- Last updated
- 21 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Effect of Male Progressive Sperm Count After Semen Pretreatment on ICSI Fertilization Outcome
- ClinicalTrials.gov ID
- NCT03594201
- Acronym / sponsor ID
- KYXM-201803
- Conditions
- Sperm Count, Low, Reproductive Sterility
- Keywords
- ICSI, progressive sperm count, embryo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,215 participants (actual)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 3 Jan 2018 (actual)
- First posted
- 20 Jul 2018 (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.
The investigators plan to retrospectively analyze clinical data from 14,189 fresh ICSI cycles in Reproductive and Genetic Hospital of CITIC-Xiangya from January 2016 to December 2017.The investigators will regard total progressive sperm number of 2 x 10^6 after pretreatment as the boundary value, and will divide total progressive sperm number of 2 x 10^6 after pretreatment into 2 x 10^6 or higher and < 2 x 10^6 groups, and will further divide < 2 x 10^6 group into: = 0, (0,10^6], (10^6, 2 x 10^6) three groups. Propensity score matching will be used to balance the baseline data between four groups. The matching variables are age, female BMI, AFC, AMH and ICSI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group1 | – | Other: semen pretreatmentA+B grade sperm count after treatment=0 |
| group2 | – | Other: semen pretreatment0<A+B grade sperm count after treatment≤10^6 |
| group3 | – | Other: semen pretreatment10^6<A+B grade sperm count after treatment<2*10^6 |
| group4 | – | Other: semen pretreatmentA+B grade sperm count after treatment≥2*10^6 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infertile couples take ART treament due to poor male semen quality.
Key inclusion criteria (1 listed)
- infertility female and sterility male for reproductive treatment
Key exclusion criteria (9 listed)
- chromosomal abnormalities
- none retrieval oocyte
- none oocyte for ICSI
- Recurrent abortion
- female age≥37 years
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 |
|---|---|---|
| semen pretreatmentsemen pretreatment | Other | group1, group2, group3, group4 |
Primary outcome
high quality embryo rate for ICSI
Time frame: two years
rate of embryo grade above 6CI on the third day after fertilization
2 secondary outcomes
fertilization rate of ICSI
Time frame: two years
normal fertilization rate of ICSI
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Individual participant dataSharing planned: No
Related trials for Sperm Count, Low
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
Not yet recruitingPhase 4
Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial
Oligoasthenoteratozoospermia, Male Infertility
Not yet recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of Multiple Dose of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia.
Oligozoospermia and/or Asthenozoospermia
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
RecruitingObservational study
Maternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men
Azoospermia, Nonobstructive, Cryptozoospermia
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.
Liang Hu, MD,PHD principal investigator
Reproductive & Genetic Hospital of CITIC-Xiangya
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 Sperm Count, Low and Reproductive Sterility, run by Reproductive & Genetic Hospital of CITIC-Xiangya 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 21 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high quality embryo rate for ICSI (time frame: two years). 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 21 May 2019.