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Male InfertilityICSI/IVF-NSMINCT03298633

ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility

A study testing ICSI and Conventional IVF in people with Male Infertility, run by Jie Qiao at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Male Infertility
What is being tested?
ICSI and Conventional IVF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,387 participants
Where
10 sitesChina
Study dates
4 Apr 2018to 31 Mar 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Infertile couples scheduled for their first or second IVF/ICSI cycle.
  • Men with non-severe male infertility: Sperm concentration 5,000,000-15,000,000/ml or sperm with progressive motility (type A+B) 10-32%.
  • Women received either gonadotrophin-releasing hormone agonist protocol or gonadotrophin-releasing hormone antagonist protocol as their controlled ovarian hyperstimulation treatment.
  • Informed consent obtained.

Who cannot join

  • Couple with contraindication for IVF or ICSI.
  • Couples receiving donor sperm or donor eggs.
  • Couples undergoing PGD and PGS.
  • Sperm concentration with progressive motility used for insemination <100,000/ml on the day of oocyte retrieval.
  • Women with 0 oocytes after oocyte retrieval.
  • Using frozen semen.
  • Poor fertilization in previous cycle (≤ 25%).

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Peking University third Hospital

    Beijing, Beijing Municipality, 100191

  • Haidian Maternal and Child Health Hospital

    Beijing, Beijing Municipality

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510150

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

  • Women's Hospital of Zhejiang University

    Hangzhou, Zhejiang

  • First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

Other trials in China

About this study

Official title: Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-severe Male Infertility: a Randomized Controlled Trial

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.

Read the detailed description

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.

Being tested
ICSI, Conventional IVF
Keywords
Male infertility, In vitro fertilization, Intracytoplasmic sperm injection
Medical subject headings
Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICSIOther

    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.

  • Conventional IVFOther

    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.

Study groups in NCT03298633
Study groupRoleWhat they receive
Intracytoplasmic Sperm InjectionActive comparatorOn 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.
Receives: Other: ICSI
Conventional IVFActive comparatorOn 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.
Receives: Other: Conventional IVF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: After 22 weeks of gestation

Secondary outcomes (21)

  1. Fertilization

    Number of zygotes with 2 PN (per oocyte retrieved and per women randomized).

    Measured: 16-20 hours after oocyte retrieval

  2. Total fertilization failure

    No oocyte formed 2 PN in this given cycle.

    Measured: 72 hours after oocyte retrieval

  3. Available embryo

    Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation.

    Measured: 72 hours after oocyte retrieval

  4. Good quality embryo

    Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation.

    Measured: 72 hours after oocyte retrieval

  5. Implantation

    Number of gestational sacs observed per embryo transferred.

    Measured: 28 days after embryo transfer

  6. 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).

    Measured: 7 weeks after embryo transfer

  7. Multiple pregnancy

    Pregnancy with two or more gestational sacs or positive heart beats at 7 weeks of gestation.

    Measured: 7 weeks after embryo transfer

  8. Ongoing pregnancy

    Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.

    Measured: 12 weeks after embryo transfer

  9. 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.

    Measured: From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assessed about 14-16 days.

  10. Miscarriage

    Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age.

    Measured: 22 weeks of gestation

  11. Ectopic pregnancy

    Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy.

    Measured: 7 weeks of gestation

  12. Gestational diabetes mellitus (GDM)

    Measured: 24-37 weeks of pregnancy

  13. Hypertensive disorders of pregnancy

    Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia.

    Measured: 28-37 weeks of pregnancy

  14. Antepartum haemorrhage

    Including placenta previa, placenta accreta and unexplained.

    Measured: 28-37 weeks of pregnancy

  15. Preterm birth

    Birth of a fetus delivered after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy.

    Measured: 28-37 weeks of pregnancy

  16. 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).

    Measured: Within 2 weeks after live birth

  17. Large for gestational age

    Birth weight >90th centile for gestation, based on standardised ethnicity based charts.

    Measured: Within 2 weeks after live birth

  18. Small for gestational age

    Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.

    Measured: Within 2 weeks after live birth

  19. Congenital anomaly

    Any congenital anomaly will be included.

    Measured: Within 2 weeks after live birth

  20. 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.

    Measured: Within 6 weeks after live birth

  21. Neonatal mortality

    death of a live born baby within 28 days of birth

    Measured: Within 6 weeks after live birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start4 Apr 2018
  3. Primary completion31 Jan 2023
  4. Study completion31 Mar 2023

Resources

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
Model description
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.
Masking
None (open label)
Enrolment
2,387 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298633
Sponsor's protocol ID
ICSI/IVF-NSMI
Acronym
ICSI/IVF-NSMI
Status last verified
Jul 2023
First submitted
22 Sep 2017
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41836350

  • 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.

    PubMed 38330980

  • 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.

    PubMed 31575574

Questions about this trial

What is this clinical trial studying?

A study testing ICSI and Conventional IVF in people with Male Infertility, run by Jie Qiao at 10 sites 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 7 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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?

Ongoing pregnancy leading to live birth after the first cycle with embryo transfer (time frame: After 22 weeks of gestation). 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 NCT03298633, 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 27 Jul 2023.

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