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| Name | Class |
|---|---|
| International Peace Maternity and Child Health Hospital | OTHER |
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
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A multicenter, parallel-controlled(1:1 treatment ratio), open-label, randomized clinical trials regarding fertilization and pregnancy outcomes between ICSI and conventional IVF among couples with no-severe male-factor infertility in China.
A multicenter, large-scale, randomized controlled clinical trial will enroll 2,346 couples with non-severe male infertility undergoing their first or second cycle of IVF or ICSI. The study will recruit participants from 6 Reproductive Medical Centers across mainland China.The participation in this study will be approximately 2 years with a total of 7 visits from controlled ovarian hyperstimulation, pregnancy to delivery. On the day of oocyte retrieval, eligible participants will be allocated to two groups at a ratio of 1:1- ICSI protocol, and conventional IVF protocol. All participants will be randomized through stratified block randomization according to the study sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracytoplasmic Sperm Injection | Active Comparator | On the day of oocyte retrieval, qualified participants will be randomized into either of two groups. Participants in group A will undergone Intracytoplasmic Sperm Injection (ICSI) procedure, other standard assisted reproductive treatments are similar and parallel between two groups. |
|
| Conventional IVF | Active Comparator | On the day of oocyte retrieval, qualified participants will be randomized into either of two groups. Participants in this group will undergone Conventional In Vitro Fertilization (IVF) procedure, other standard assisted reproductive treatments are similar and parallel between two groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICSI | Other | All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either gonadotrophin-releasing hormone agonist (GnRH-a) protocol or gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol.Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be allocated to undergo routine ICSI procedure according to the result of randomization in each study site. |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy leading to live birth after the first cycle with embryo transfer | A delivery of one or more living infants (≥22 weeks gestation or birth weight more than 1,000g). | After 22 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization | Number of zygotes with 2 PN (per oocyte retrieved and per women randomized). | 16-20 hours after oocyte retrieval |
| Total fertilization failure | No oocyte formed 2 PN in this given cycle. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Qiao, M.D. | Peking University Third Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China | ||
| Peking University third Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41836350 | Derived | Wang Y, Wang R, Lian Y, Yang R, Gao J, Liu J, Tang L, Liang X, Cao Y, Li W, Jin L, Zhu Y, Zhao J, Hao G, Wang H, Mol BW, Li R, Qiao J. Evaluating the potential for sperm DNA fragmentation testing to guide the use of ICSI for couples with non-severe male infertility. Hum Reprod Open. 2026 Mar 7;2026(2):hoag011. doi: 10.1093/hropen/hoag011. eCollection 2026. | |
| 38330980 |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D020554 | Sperm Injections, Intracytoplasmic |
| ID | Term |
|---|---|
| D005307 | Fertilization in Vitro |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
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| First Affiliated Hospital of Kunming Medical University | OTHER |
| Beijing Haidian Maternal and Child Health Hospital | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| The Third Affiliated Hospital of Guangzhou Medical University | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
Eligible patients that have provided informed consent will be randomized to either ICSI or conventional IVF. Randomization and allocation of patients to study groups will be performed on the day of oocyte retrieval. Stratified permuted block randomization will be centrally controlled by administrative staffs in the trial center, who are not involved in the treatment procedure. When there is an eligible participant to be enrolled into the study, nurses from the specific site will login the trial system to get allocation of patients according to a computer-generated randomization list in a 1:1 ratio, with a variable block size of 2, 4 or 8 and stratified by center.
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The blinding method in out study is open-label in general. However, in order to avoid psychological effect for participants and unexpected drop-off, the trial is designed to inform participants their insemination method on the day of fresh embryo transfer or the day of embryo freezing. Prior to this, randomization will be strictly performed and keep secret to participants and clinicians.
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|
| Conventional IVF | Other | All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either gonadotrophin-releasing hormone agonist (GnRH-a) protocol or gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol.Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be allocated to undergo conventional IVF procedure according to the result of randomization in each study site. |
|
| 72 hours after oocyte retrieval |
| Available embryo | Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation. | 72 hours after oocyte retrieval |
| Good quality embryo | Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation. | 72 hours after oocyte retrieval |
| Implantation | Number of gestational sacs observed per embryo transferred. | 28 days after embryo transfer |
| Clinical pregnancy | One or more observed gestational sac or definitive clinical signs of pregnancy under ultrasonography at 7 weeks after embryo transfer (including clinically documented ectopic pregnancy). | 7 weeks after embryo transfer |
| Multiple pregnancy | Pregnancy with two or more gestational sacs or positive heart beats at 7 weeks of gestation. | 7 weeks after embryo transfer |
| Ongoing pregnancy | Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation. | 12 weeks after embryo transfer |
| Moderate/severe ovarian hyperstimulation syndrome (OHSS) | exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate, or severe according to the degree of abdominal distention, ovarian Enlargement, and respiratory, hemodynamic, and metabolic complications. | From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assessed about 14-16 days. |
| Miscarriage | Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age. | 22 weeks of gestation |
| Ectopic pregnancy | Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy. | 7 weeks of gestation |
| Gestational diabetes mellitus (GDM) | 24-37 weeks of pregnancy |
| Hypertensive disorders of pregnancy | Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia. | 28-37 weeks of pregnancy |
| Antepartum haemorrhage | Including placenta previa, placenta accreta and unexplained. | 28-37 weeks of pregnancy |
| Preterm birth | Birth of a fetus delivered after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy. | 28-37 weeks of pregnancy |
| Birth weight | Including low birth weight (defined as weight < 2500 gm at birth), very low birth weight (defined as < 1500 gm at birth), high birth weight (defined as >4000 gm at birth) and very high birth weight (defined as >4500 gm at birth). | Within 2 weeks after live birth |
| Large for gestational age | Birth weight >90th centile for gestation, based on standardised ethnicity based charts. | Within 2 weeks after live birth |
| Small for gestational age | Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts. | Within 2 weeks after live birth |
| Congenital anomaly | Any congenital anomaly will be included. | Within 2 weeks after live birth |
| Perinatal mortality | Fetal or neonatal death occurring during late pregnancy (at 28 completed weeks of gestational age and later), during childbirth, or up to seven completed days after birth. | Within 6 weeks after live birth |
| Neonatal mortality | death of a live born baby within 28 days of birth | Within 6 weeks after live birth |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| Haidian Maternal and Child Health Hospital | Beijing | Beijing Municipality | China |
| The Third Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510150 | China |
| The Sixth Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
| International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| Women's Hospital of Zhejiang University | Hangzhou | Zhejiang | China |
| Wang Y, Li R, Yang R, Zheng D, Zeng L, Lian Y, Zhu Y, Zhao J, Liang X, Li W, Liu J, Tang L, Cao Y, Hao G, Wang H, Zhang H, Wang R, Mol BW, Huang H, Qiao J. Intracytoplasmic sperm injection versus conventional in-vitro fertilisation for couples with infertility with non-severe male factor: a multicentre, open-label, randomised controlled trial. Lancet. 2024 Mar 9;403(10430):924-934. doi: 10.1016/S0140-6736(23)02416-9. Epub 2024 Feb 5. |
| 31575574 | Derived | Zheng D, Zeng L, Yang R, Lian Y, Zhu YM, Liang X, Tang L, Wang H, Cao Y, Hao G, Liu J, Zhao J, Wang R, Mol BW, Li R, Huang HF, Qiao J. Intracytoplasmic sperm injection (ICSI) versus conventional in vitro fertilisation (IVF) in couples with non-severe male infertility (NSMI-ICSI): protocol for a multicentre randomised controlled trial. BMJ Open. 2019 Sep 30;9(9):e030366. doi: 10.1136/bmjopen-2019-030366. |
| D052801 |
| Male Urogenital Diseases |
| D008919 | Investigative Techniques |