NCT03428919

Brief Summary

Conventionally, ICSI was initially developed and has been shown to be an effective treatment for male factor infertility. It is increasingly being used for patients without a male factor diagnosis, despite the lack of clinical evidence to support its use. Moreover, ICSI is an invasive and expensive procedure. This multi-center, randomized, controlled, parallel-group trial will be conducted to compare the effectiveness of ICSI versus conventional IVF in infertile couples scheduled for IVF treatment, in whom the male partner has normal sperm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,064

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 16, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2020

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

2.4 years

First QC Date

February 2, 2018

Last Update Submit

October 7, 2020

Conditions

Infertility

Keywords

ICSIConventional IVFNon-male factor

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle.

    Live birth is defined as the birth of at least one newborn after 24 weeks' gestation that exhibits any sign of life (twin will be a single count). For the timing of this occur, ongoing pregnancy will be used, conditional on the fact that this ongoing pregnancy results in live birth.

    At 12 weeks of gestation

Secondary Outcomes (57)

  • Fertilization rate per oocyte inseminated/injected

    At 16-18 hours after injected or 17-19 hours after inseminated

  • Fertilization rate per oocyte retrieved

    At 16-18 hours after injected or 17-19 hours after inseminated

  • Abnormal fertilization rate

    At 16-18 hours after injected or 17-19 hours after inseminated

  • Total fertilization failure rate

    At 16-18 hours after injected or 17-19 hours after inseminated

  • Number of embryos on day 3

    3 days after oocytes pick-up day in IVF/ICSI

  • +52 more secondary outcomes

Study Arms (2)

Intracytoplasmic Sperm Injection (ICSI)

ACTIVE COMPARATOR

All patients will be treated with a GnRH antagonist protocol. hCG (Ovitrelle 250 mg) will be used in the presence of at least three leading follicles of 17 mm. In women with ≥15 follicles ≥12 mm, 0,2 mg Triptorelin (Diphereline) will be used when there is at least two leading follicles of 17 mm. Oocyte retrieval will be performed 36 hours after triggering. Insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. OCCs will be stripped by using hyaluronidase. Only matured oocytes will be inseminated. Fertilization check will be performed at period of 16-18 hours after insemination. Embryo transfer will be performed on day 3 under ultrasound guidance. A maximum of 2 embryos will be transferred into the uterus. The remaining grade 1 and 2 embryos will be frozen.

Procedure: ICSI

In Vitro Fertilization (IVF)

ACTIVE COMPARATOR

All patients will be treated with a GnRH antagonist protocol. hCG (Ovitrelle 250 mg) will be used in the presence of at least three leading follicles of 17 mm. In women with ≥15 follicles ≥12 mm, 0,2 mg Triptorelin (Diphereline) will be used when there is at least two leading follicles of 17 mm. Oocyte retrieval will be performed 36 hours after triggering. Insemination will be performed by conventional IVF. Two hours after retrieval, collected OCCs will be inseminated for another 2 hours (100,000 motile sperm/ml). Inseminated OCCs will be cultured overnight in culture medium. Fertilization check will be performed at period of 16-18 hours after insemination. Embryo transfer will be performed on day 3. A maximum of 2 embryos will be transferred. The remaining grade 1-2 embryos will be frozen.

Procedure: IVF

Interventions

ICSIPROCEDURE

In ICSI group, insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. OCCs will be stripped by using hyaluronidase. Only matured oocytes will be inseminated.

Intracytoplasmic Sperm Injection (ICSI)
IVFPROCEDURE

In IVF group, insemination will be performed by conventional IVF. Two hours after retrieval, collected OCCs will be inseminated for another 2 hours, at a concentration of 100,000 motile sperm/ml. Inseminated OCCs will be cultured overnight in culture medium.

In Vitro Fertilization (IVF)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having ≤ 2 IVF/ICSI cycles
  • Total sperm count and motility are normal (WHO, 2010)
  • Antagonist protocol
  • Agree to have ≤ 2 embryos transferred
  • Not participating in another IVF study at the same time

You may not qualify if:

  • In-vitro maturation (IVM) cycles
  • Using frozen semen
  • Poor fertilization in previous cycle (≤ 25%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dang Q Vinh

Hochiminh City, Vietnam

Location

Related Publications (4)

  • Pham TD, Dang VQ, Ho VNA, Tran CT, Nguyen DTP, Vuong LN, Ho TM, Mol BW, Wang R. Intracytoplasmic sperm injection versus conventional in vitro fertilization in infertile couples with normal total sperm count and motility: does sperm morphology matter? Hum Reprod. 2025 Jan 1;40(1):23-29. doi: 10.1093/humrep/deae252.

    PMID: 39547931DERIVED

  • Nguyen NA, Nguyen NT, Tran VTT, Vo TTM, Uong TS, Nguyen HT, Nguyen NT, Nguyen DL, Pham TD, Nguyen DTN, Ho TM, Vuong LN. Developmental outcomes of children born through ICSI versus conventional IVF (cIVF) in couples with non-male factor infertility. Hum Reprod. 2024 Jun 5:deae120. doi: 10.1093/humrep/deae120. Online ahead of print.

    PMID: 38840410DERIVED

  • Dang VQ, Vuong LN, Luu TM, Pham TD, Ho TM, Ha AN, Truong BT, Phan AK, Nguyen DP, Pham TN, Pham QT, Wang R, Norman RJ, Mol BW. Intracytoplasmic sperm injection versus conventional in-vitro fertilisation in couples with infertility in whom the male partner has normal total sperm count and motility: an open-label, randomised controlled trial. Lancet. 2021 Apr 24;397(10284):1554-1563. doi: 10.1016/S0140-6736(21)00535-3.

    PMID: 33894833DERIVED

  • Dang VQ, Vuong LN, Ho TM, Ha AN, Nguyen QN, Truong BT, Pham QT, Wang R, Norman RJ, Mol BW. The effectiveness of ICSI versus conventional IVF in couples with non-male factor infertility: study protocol for a randomised controlled trial. Hum Reprod Open. 2019 Mar 27;2019(2):hoz006. doi: 10.1093/hropen/hoz006. eCollection 2019.

    PMID: 30937394DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Lan N Vuong, PhD

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 12, 2018

Study Start

March 16, 2018

Primary Completion

August 1, 2020

Study Completion

August 12, 2020

Last Updated

October 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)