An interventional study of ICSI and Conventional IVF in Male Infertility, sponsored by Jie Qiao. Completed at 10 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Jie Qiao · Not applicable, Interventional, and Treatment
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Among 10 studies in Infertility, Male with a site in China — 3 open to participants now, 3 under way, none of them phase 3. Infertility, Male · China.
Among the 10 studies in Infertility, Male with a site in China, this one is the only one that started in 2018, is one of 4 with no phase, and was the 3rd registered.
282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.
Browse Infertility, Male studies →3 of the 10 studies in Infertility, Male with a site in China are open now. Recruiting first, the newest first:
ShangHai Ji Ai Genetics & IVF Institute · Sites in China
Ages 20–37
Zhujiang Hospital · Sites in China
Ages 18–45 · Men only · Healthy volunteers
The Third Affiliated Hospital of Guangzhou Medical University · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 40 Infertility, Male studies recruiting now, 16 (40%) set no upper age limit and 24 (60%) stop at 75 or younger; 7 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 1 started in 2018.
This study's enrollment of 2,387 is above the median of 80 across 187 interventional studies indexed under Infertility, Male.
Median enrollment 134 across the 6 interventional studies, 753 across the 4 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 9 most frequent:
Jie Qiao is the lead sponsor of 2 studies on the registry; none are open to participants now.
Jie Qiao has 1 study filed under Infertility, Male — fewer than ten, so there is no comparison to draw.
2 of the studies in Infertility, Male with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06561451ShangHai Ji Ai Genetics & IVF InstituteLive Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia | 2026-12-30 |
| NCT07691827The Third Affiliated Hospital of Guangzhou Medical UniversityMaternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men | 2027-04-01 |
Add all 2 to your calendar (.ics) → With an account.
Among the 10 studies in Infertility, Male with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: ICSI
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.
Other: Conventional IVF
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.
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.
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).
Time frame: After 22 weeks of gestation
Fertilization
Number of zygotes with 2 PN (per oocyte retrieved and per women randomized).
Time frame: 16-20 hours after oocyte retrieval
Total fertilization failure
No oocyte formed 2 PN in this given cycle.
Time frame: 72 hours after oocyte retrieval
Available embryo
Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation.
Time frame: 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.
Time frame: 72 hours after oocyte retrieval
Implantation
Number of gestational sacs observed per embryo transferred.
Time frame: 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).
Time frame: 7 weeks after embryo transfer
Multiple pregnancy
Pregnancy with two or more gestational sacs or positive heart beats at 7 weeks of gestation.
Time frame: 7 weeks after embryo transfer
Ongoing pregnancy
Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.
Time frame: 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.
Time frame: 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.
Time frame: 22 weeks of gestation
Ectopic pregnancy
Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy.
Time frame: 7 weeks of gestation
Gestational diabetes mellitus (GDM)
Time frame: 24-37 weeks of pregnancy
Hypertensive disorders of pregnancy
Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia.
Time frame: 28-37 weeks of pregnancy
Antepartum haemorrhage
Including placenta previa, placenta accreta and unexplained.
Time frame: 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.
Time frame: 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).
Time frame: Within 2 weeks after live birth
Large for gestational age
Birth weight \>90th centile for gestation, based on standardised ethnicity based charts.
Time frame: 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.
Time frame: Within 2 weeks after live birth
Congenital anomaly
Any congenital anomaly will be included.
Time frame: 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.
Time frame: Within 6 weeks after live birth
Neonatal mortality
death of a live born baby within 28 days of birth
Time frame: Within 6 weeks after live birth
Plan to share: No
Ran from Apr 2018 to primary completion in Jan 2023, 57 months.
Of 77 non-industry interventional studies with no phase under Infertility, Male, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's 57 months is above that.
Counting every sponsor, half of 92 studies reached it within 34 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Jie Qiao