Infertility, MaleNCT02941965
Preimplantation Genetic Screening in Patients With Male Factor Infertility
A study testing ICSI without PGS and ICSI with PGS in people with Infertility, Male and Diagnosis, Preimplantation, run by International Peace Maternity and Child Health Hospital at 1 site in China.
Trial summary
This will be a prospective, randomized (1:1 ratio) clinical trial for patients with severe male-factor infertility with or without preimplantation genetic screening (PGS). Qualified 450 patients are randomized into either of two groups: group A will undergo intracytoplasmic sperm injection (ICSI) without PGS (225… Read more about this study
- Who is it for?
- Ages 20 to 55 years, men only
- Conditions the study is for
- Infertility, Male, Diagnosis, Preimplantation
- What is being tested?
- ICSI without PGS and ICSI with PGS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2017to 30 Jun 2023
- Phase
- Interventional
- 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 20 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male partner age of 20-55 years old, Chinese.
- Male partner has severe male infertility (defined as a semen concentrate less than 5×10^6/ml, and/or with a progressive motility less than 10%).
- Proposed ICSI to assist pregnancy.
- Fully explain the nature of the research and obtain the informed consent of the subject before carrying out any procedure in the research protocol. If a subject is not capable of expressing opinions, the legal representative of the subject can sign the informed consent on behalf of the subject.
Who cannot join
- Any one of the following criteria should be excluded from this study:
- Male partner had been diagnosed with obstructive azoospermia, sexual dysfunction, and immune infertility.
- Female partner at 38 years of ages and older.
- Female partner has uterine abnormalities such as uterine malformations (unicornuate uterus, mediastinal uterus, double uterus, double horn uterus, etc.), adenomyosis, submucosal fibroids or intrauterine adhesions.
- Female partner has a history of recurrent abortion, including biochemical pregnancy (≥3 time miscarriages).
- One of the couples has abnormal chromosomal karyotypes, excluding chromosomal polymorphisms.
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- Female partner has contraindications for assisted reproduction, such as poorly controlled type I or type II diabetes mellitus; undiagnosed liver disease or abnormal liver function (abnormal serum liver enzymes); kidney disease or abnormal kidney function; severe anemia; history of deep venous thrombosis; history of pulmonary embolism; history of cerebrovascular accident; poorly controlled hypertension or diagnosed heart disease; history of cervical cancer, endometrial cancer or breast cancer; unexplained vaginal bleeding.
- Male partner has contraindications for assisted reproduction, such as poorly controlled type I or type II diabetes mellitus; undiagnosed liver disease or abnormal liver function (abnormal serum liver enzymes); kidney disease or abnormal kidney function; severe anemia; history of deep venous thrombosis; history of pulmonary embolism; history of cerebrovascular accident; poorly controlled hypertension or diagnosed heart disease.
- One of the couple refuses to cooperate with the study.
- Patients who have been included in the experimental group or control group of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
International Peace Maternity & Child Health Hospital
Shanghai, Shanghai Municipality, 200030
He-feng Huang, MD, +86-21-18017310186, hefenghuang@126.com
About this study
This will be a prospective, randomized (1:1 ratio) clinical trial for patients with severe male-factor infertility with or without preimplantation genetic screening (PGS). Qualified 450 patients are randomized into either of two groups: group A will undergo intracytoplasmic sperm injection (ICSI) without PGS (225 cases), Group B will undergo ICSI with PGS (225 cases). The partners of all participants will receive the same protocol for ovarian stimulation and standardized luteal phase support.
The target population will be patients with severe male-factor infertility aged between 20 and 55 years, diagnosed by the ESHER Criteria (Non-obstructive oligospermia，asthenspermia). Women with other reasons of infertility (eg. advanced age, anovulation, endometriosis, and premature ovarian failure) are excluded.
The randomization will take place 3-6 days after the oocyte pick-up day by a computer randomization system. The pregnancy test results, pregnancy complications, congenital anomalies, neonatal complications will be followed up by checking medical records and telephone calls.
- Conditions
- Infertility, Male, Diagnosis, Preimplantation
- Being tested
- ICSI without PGS, ICSI with PGS
- Medical subject headings
- Infertility, Male, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSI without PGSProcedure or surgery
Selection of embryos are based on morphology criteria on the 5th day of ICSI.
ICSI with PGSProcedure or surgery
PGS will be applied to selected embryos on the 5th day of ICSI.
| Study group | Role | What they receive |
|---|---|---|
| ICSI without PGS | Experimental | Selection of embryos are based on blastocyst morphology criteria on day 5. A maximum of 2 embryos will be transferred for each treatment cycle. Receives: Procedure: ICSI without PGS |
| ICSI with PGS | Experimental | PGS will be applied to select embryos on day 5, only euploid embryos will be transferred.
A maximum of 2 embryos will be transferred for each treatment cycle. Receives: Procedure: ICSI with PGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
This will be based on the outcome of either the PGS+ICSI or the outcome of the ICSI after first embryo transfer cycle.
Measured: 42 weeks
Secondary outcomes (7)
clinical pregnancy rate
Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
Measured: 35 days after embryo transfer
implantation rate
Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.
Measured: 11-12 weeks after embryo transfer
biochemical pregnancy rate
Biochemical pregnancy was defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.
Measured: 2 weeks after embryo transfer
pregnancy loss rate
Pregnancy loss is defined as any reason that resulted in failure of an embryo to develop, embryonic or fetal death, or spontaneous expulsion of a pregnancy.
Measured: 28 gestational weeks in maximum
ectopic pregnancy rate
Ectopic pregnancy is defined as an embryo implanted outside the uterine.
Measured: 12 gestational weeks in maximum
Congenital Anomalies rate
Congenital anomaly included deformity and development abnormality of any organs or systems.
Measured: 1 day after delivery
neonatal complication rate
Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.
Measured: 1 day after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start18 Jul 2017
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He-Feng Huang, International Peace Maternity and Child Health Hospital
- Investigators
- He-Feng Huang, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941965
- Sponsor's protocol ID
- IPMCH2016001
- Status last verified
- Jun 2022
- First submitted
- 19 Oct 2016
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin X, Wu D, Zhang C, Wang L, Lu Y, Zhou P, Zhou C, Jin L, Wang L, Zhu H, Pan J, Xu C, Chen S, Gao L, Li L, Zhang S, Wu Y, Sun Y, Mol BW, Huang H. Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial. BMJ. 2025 Dec 23;391:e084050. doi: 10.1136/bmj-2025-084050.
PubMed 41436190Lin XH, Guo MX, Wu DD, Lu Y, Zhang JL, Zhou CL, Jin L, Wang L, Zhang C, Xu CM, Chen SC, Zhang SY, Sun XX, Wu YT, Sun Y, Huang HF. Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial. BMJ Open. 2022 Jul 13;12(7):e063030. doi: 10.1136/bmjopen-2022-063030.
PubMed 35831058Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
PubMed 32898291
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preimplantation Genetic Screening in Patients With Male Factor Infertility
- ClinicalTrials.gov ID
- NCT02941965
- Acronym / sponsor ID
- IPMCH2016001
- Conditions
- Infertility, Male, Diagnosis, Preimplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 21 Oct 2016 (estimated)
- 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.
This will be a prospective, randomized (1:1 ratio) clinical trial for patients with severe male-factor infertility with or without preimplantation genetic screening (PGS). Qualified 450 patients are randomized into either of two groups: group A will undergo intracytoplasmic sperm injection (ICSI) without PGS (225 cases), Group B will undergo ICSI with PGS (225 cases). The partners of all participants will receive the same protocol for ovarian stimulation and standardized luteal phase support.
The target population will be patients with severe male-factor infertility aged between 20 and 55 years, diagnosed by the ESHER Criteria (Non-obstructive oligospermia，asthenspermia). Women with other reasons of infertility (eg. advanced age, anovulation, endometriosis, and premature ovarian failure) are excluded.
The randomization will take place 3-6 days after the oocyte pick-up day by a computer randomization system. The pregnancy test results, pregnancy complications, congenital anomalies, neonatal complications will be followed up by checking medical records and telephone calls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICSI without PGS | Experimental | Procedure: ICSI without PGSSelection of embryos are based on blastocyst morphology criteria on day 5. A maximum of 2 embryos will be transferred for each treatment cycle. |
| ICSI with PGS | Experimental | Procedure: ICSI with PGSPGS will be applied to select embryos on day 5, only euploid embryos will be transferred. A maximum of 2 embryos will be transferred for each treatment cycle. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male partner age of 20-55 years old, Chinese.
- Male partner has severe male infertility (defined as a semen concentrate less than 5×10^6/ml, and/or with a progressive motility less than 10%).
- Proposed ICSI to assist pregnancy.
- Fully explain the nature of the research and obtain the informed consent of the subject before carrying out any procedure in the research protocol. If a subject is not capable of expressing opinions, the legal representative of the subject can sign the informed consent on behalf of the subject.
Key exclusion criteria (10 listed)
- Male partner had been diagnosed with obstructive azoospermia, sexual dysfunction, and immune infertility.
- Female partner at 38 years of ages and older.
- Female partner has uterine abnormalities such as uterine malformations (unicornuate uterus, mediastinal uterus, double uterus, double horn uterus, etc.), adenomyosis, submucosal fibroids or intrauterine adhesions.
- Female partner has a history of recurrent abortion, including biochemical pregnancy (≥3 time miscarriages).
- One of the couples has abnormal chromosomal karyotypes, excluding chromosomal polymorphisms.
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 |
|---|---|---|
| ICSI without PGSSelection of embryos are based on morphology criteria on the 5th day of ICSI. | Procedure or surgery | ICSI without PGS |
| ICSI with PGSPGS will be applied to selected embryos on the 5th day of ICSI. | Procedure or surgery | ICSI with PGS |
Primary outcome
live birth rate
Time frame: 42 weeks
This will be based on the outcome of either the PGS+ICSI or the outcome of the ICSI after first embryo transfer cycle.
7 secondary outcomes
clinical pregnancy rate
Time frame: 35 days after embryo transfer
implantation rate
Time frame: 11-12 weeks after embryo transfer
biochemical pregnancy rate
Time frame: 2 weeks after embryo transfer
pregnancy loss rate
Time frame: 28 gestational weeks in maximum
ectopic pregnancy rate
Time frame: 12 gestational weeks in maximum
Congenital Anomalies rate
Time frame: 1 day after delivery
neonatal complication rate
Time frame: 1 day after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Derived from this study: PubMed 41436190Lin X, Wu D, Zhang C, Wang L, Lu Y, Zhou P, Zhou C, Jin L, Wang L, Zhu H, Pan J, Xu C, Chen S, Gao L, Li L, Zhang S, Wu Y, Sun Y, Mol BW, Huang H. Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial. BMJ. 2025 Dec 23;391:e084050. doi: 10.1136/bmj-2025-084050.
- Derived from this study: PubMed 35831058Lin XH, Guo MX, Wu DD, Lu Y, Zhang JL, Zhou CL, Jin L, Wang L, Zhang C, Xu CM, Chen SC, Zhang SY, Sun XX, Wu YT, Sun Y, Huang HF. Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial. BMJ Open. 2022 Jul 13;12(7):e063030. doi: 10.1136/bmjopen-2022-063030.
- Derived from this study: PubMed 32898291Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
- Individual participant dataSharing planned: No
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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.
He-Feng Huang principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICSI without PGS and ICSI with PGS in people with Infertility, Male and Diagnosis, Preimplantation, run by International Peace Maternity and Child Health Hospital 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 4 inclusion and 10 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 6 Jun 2022. 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 He-Feng Huang, MD (+86-21-18017310186, hefenghuang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: 42 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941965, which also lists 3 linked publications.
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 6 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.