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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICSI without PGS | Procedure | Selection of embryos are based on morphology criteria on the 5th day of ICSI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 42 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate | Clinical pregnancy was defined as an observation of gestational sac via ultrasonography. | 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. |
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Inclusion criteria
Exclusion criteria
Any one of the following criteria should be excluded from this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He-Feng Huang, MD | Contact | +86-21-18017310186 | hefenghuang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| He-Feng Huang | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Peace Maternity & Child Health Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41436190 | Derived | 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. | |
| 35831058 |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D020554 | Sperm Injections, Intracytoplasmic |
| D010715 | Phosphatidylglycerols |
| ID | Term |
|---|---|
| D005307 | Fertilization in Vitro |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
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| ICSI with PGS | Procedure | PGS will be applied to selected embryos on the 5th day of ICSI. |
|
| 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. | 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. | 28 gestational weeks in maximum |
| ectopic pregnancy rate | Ectopic pregnancy is defined as an embryo implanted outside the uterine. | 12 gestational weeks in maximum |
| Congenital Anomalies rate | Congenital anomaly included deformity and development abnormality of any organs or systems. | 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. | 1 day after delivery |
| Derived |
| Lin 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. |
| 32898291 | Derived | Cornelisse 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. |
| D052801 |
| Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |