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ICSI Versus Conventional IVF in Non-male Factor Couples

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ClinicalTrials.gov Identifier: NCT03428919
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
An Sinh Hospital
Information provided by (Responsible Party):
Mỹ Đức Hospital

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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: ICSI Procedure: IVF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1064 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Intracytoplasmic Sperm Injection Versus Conventional in Vitro Fertilization in Couples With Non-male Factor Infertility: a Randomized Controlled Trial
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : August 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: Intracytoplasmic Sperm Injection (ICSI)

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 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.

Active Comparator: In Vitro Fertilization (IVF)

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
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.




Primary Outcome Measures :
  1. Ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle. [ Time Frame: At 12 weeks of gestation ]

    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.



Secondary Outcome Measures :
  1. Fertilization rate per oocyte inseminated/injected [ Time Frame: At 16-18 hours after injected or 17-19 hours after inseminated ]
    Fertilization is defined as the appearance of 2 PN

  2. Fertilization rate per oocyte retrieved [ Time Frame: At 16-18 hours after injected or 17-19 hours after inseminated ]
    Fertilization is defined as the appearance of 2 PN

  3. Abnormal fertilization rate [ Time Frame: At 16-18 hours after injected or 17-19 hours after inseminated ]
    Abnormal fertilization is defined as the appearance of 1PN or ≥3 PN

  4. Total fertilization failure rate [ Time Frame: At 16-18 hours after injected or 17-19 hours after inseminated ]
    Total fertilization is defined as the absence of any zygotes with 2PN

  5. Number of embryos on day 3 [ Time Frame: 3 days after oocytes pick-up day in IVF/ICSI ]
    Number of embryos on day 3

  6. Number of good quality embryo on day 3 [ Time Frame: 3 days after oocytes pick-up day in IVF/ICSI ]
    Numbers of embryos on day 3 with good quality

  7. Number of embryo freezing on day 3 [ Time Frame: 3 days after oocytes pick-up day in IVF/ICSI ]
    Number of embryos freezing on day 3

  8. Positive pregnancy test [ Time Frame: 14 days after embryo transfer ]
    Positive pregnancy test is defined as a serum human chorionic gonadotropin level greater than 25 mIU/mL after the completion of the first transfer

  9. Clinical pregnancy [ Time Frame: At 7 weeks' gestation ]
    Clinical pregnancy is defined as the presence of at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity, after the completion of the first transfer

  10. Implantation rate [ Time Frame: At 3 weeks after embryo transferred ]
    Implantation rate is defined as the number of gestational sacs per number of embryos transferred after the completion of the first transfer

  11. Ongoing pregnancy [ Time Frame: At 12 weeks' gestation ]
    Ongoing pregnancy is defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after the completion of the first transfer

  12. Cumulative ongoing pregnancy [ Time Frame: At 12 weeks' gestation at 12 months after randomization. After 12 months, most patients doing IVF have finished all their frozen embryos; therefore, we consider this time point for analyzing the cumulative ongoing pregnancy rate. ]
    Ongoing pregnancy is defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after transfer of all embryos from the started treatment cycle.

  13. Ongoing pregnancy resulting in live birth obtained from all embryos from the first started treatment cycle [ Time Frame: 12 weeks of gestation at 12 months after randomization ]
    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).

  14. Time from randomization to ongoing pregnancy [ Time Frame: 12 weeks of gestation after the completion of first transfer ]
    Time from randomization to ongoing pregnancy after the completion of the first transfer

  15. Ovarian hyperstimulation syndrome (OHSS) [ Time Frame: At 10 days after hCG injection and 14 days after embryo transfer ]
    Symptoms of OHSS

  16. Ectopic pregnancy [ Time Frame: At 12 weeks of gestation after the completion of the first transfer ]
    A pregnancy in which implantation takes place outside the uterine cavity after completion of the first transfer

  17. Ectopic pregnancy [ Time Frame: At 12 weeks of gestation at 12 months after randomization. ]
    A pregnancy in which implantation takes place outside the uterine cavity after transfer of all embryos from the started treatment cycle.

  18. Miscarriage [ Time Frame: At 24 weeks of gestation after the completion of the first transfer ]
    The loss of a clinical pregnancy at 24 weeks of gestation after the completion of the first transfer

  19. Miscarriage [ Time Frame: At 24 weeks of gestation at 12 months after the randomization. ]
    The loss of a clinical pregnancy at 24 weeks of gestation after the completion transfer of all embryos from the started treatment cycle

  20. Multiple pregnancy [ Time Frame: 7 weeks' gestation after the completion of the first transfer ]
    Multiple pregnancy is explained as two or more gestational sacs or positive heart beats by transvaginal sonography, after the completion of the first transfer

  21. Multiple pregnancy [ Time Frame: 7 weeks' gestation at 12 months after randomization ]
    Multiple pregnancy is explained as two or more gestational sacs or positive heart beats by transvaginal sonography, after the completion transfer of all embryos from the started treatment cycle

  22. Multiple delivery [ Time Frame: At birth, after the completion of the first transfer ]
    Multiple delivery is defined as birth of more than one baby beyond 24 weeks, after the completion of the first transfer

  23. Multiple delivery [ Time Frame: At birth at 12 months after randomization ]
    Multiple delivery is defined as birth of more than one baby beyond 24 weeks, after the completion transfer of all embryos from the started treatment cycle

  24. Gestational diabetes mellitus [ Time Frame: At 24 weeks of gestation after the completion of the first transfer ]
    Development of diabetes during pregnancy

  25. Gestational diabetes mellitus [ Time Frame: At 24 weeks of gestation at 12 months after randomization ]
    Development of diabetes during pregnancy

  26. Hypertensive disorders of pregnancy [ Time Frame: From 20 weeks of gestation up to at birth after the completion of the first transfer ]
    Hypertensive disorders of pregnancy will include pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia)

  27. Hypertensive disorders of pregnancy [ Time Frame: From 20 weeks of gestation up to at birth at 12 months after randomization ]
    Hypertensive disorders of pregnancy will include pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia)

  28. Antepartum haemorrhage [ Time Frame: From 20 weeks of gestation up to at birth, after the completion of the first transfer ]
    Including placenta previa, placenta accreta and unexplained

  29. Antepartum haemorrhage [ Time Frame: From 20 weeks of gestation up to at birth, at 12 months after randomization ]
    Including placenta previa, placenta accreta and unexplained

  30. Gestational age at delivery [ Time Frame: At birth, after the completion of the first transfer ]
    Gestational age at delivery

  31. Gestational age at delivery [ Time Frame: At birth, at 12 months after randomization ]
    Gestational age at delivery

  32. Preterm delivery [ Time Frame: At birth, after the completion of the first transfer ]
    Preterm delivery is defined as any delivery at <24, <28, <32, <37 completed weeks' gestation

  33. Preterm delivery [ Time Frame: At birth, at 12 months after randomization ]
    Preterm delivery is defined as any delivery at <24, <28, <32, <37 completed weeks' gestation

  34. Spontaneous preterm birth [ Time Frame: At birth, after the completion of the first transfer ]
    Spontaneous preterm birth is defined as delivery spontaneously at <24, <28, <32, <37 completed weeks

  35. Spontaneous preterm birth [ Time Frame: At birth, at 12 months after randomization ]
    Spontaneous preterm birth is defined as delivery spontaneously at <24, <28, <32, <37 completed weeks

  36. Iatrogenic preterm birth [ Time Frame: At birth, after the completion of the first transfer ]
    Iatrogenic preterm birth is defined as delivery non-spontaneously at <24, <28, <32, <37 completed weeks

  37. Iatrogenic preterm birth [ Time Frame: At birth, at 12 months after randomization ]
    Iatrogenic preterm birth is defined as delivery non-spontaneously at <24, <28, <32, <37 completed weeks

  38. Birth weight [ Time Frame: At birth, after the completion of the first transfer ]
    Weight of newborn

  39. Birth weight [ Time Frame: At birth, at 12 months after randomization ]
    Weight of newborn

  40. Low birth weight [ Time Frame: At birth, after the completion of the first transfer ]
    Low birth weight is defined as <2500 gm

  41. Low birth weight [ Time Frame: At birth, at 12 months after randomization ]
    Low birth weight is defined as <2500 gm

  42. Very low birth weight [ Time Frame: At birth, after the completion of the first transfer ]
    Very low birth weight is defined as <1500 gm

  43. Very low birth weight [ Time Frame: At birth, at 12 months after randomization ]
    Very low birth weight is defined as <1500 gm

  44. High birth weight [ Time Frame: At birth, after the completion of the first transfer ]
    High birth weight is defined as >4000 gm

  45. High birth weight [ Time Frame: At birth, at 12 months after randomization ]
    High birth weight is defined as >4000 gm

  46. Very high birth weight [ Time Frame: At birth, after the completion of the first transfer ]
    Very high birth weight is defined as >4500 gm

  47. Very high birth weight [ Time Frame: At birth, at 12 months after randomization ]
    Very high birth weight is defined as >4500 gm

  48. Large for gestational age [ Time Frame: At birth, after the completion of the first transfer ]
    Large for gestational age is defined as birth weight >90th percentile

  49. Large for gestational age [ Time Frame: At birth, at 12 months after randomization ]
    Large for gestational age is defined as birth weight >90th percentile

  50. Small for gestational age [ Time Frame: At birth, after the completion of the first transfer ]
    Small for gestational age is defined as birth weight <10th percentile

  51. Small for gestational age [ Time Frame: At birth, at 12 months after randomization ]
    Small for gestational age is defined as birth weight <10th percentile

  52. Congenital anomaly diagnosed at birth [ Time Frame: At birth, after the completion of the first transfer ]
    Any congenital anomaly will be included

  53. Congenital anomaly diagnosed at birth [ Time Frame: At birth, at 12 months after randomization ]
    Any congenital anomaly will be included

  54. Admission to NICU [ Time Frame: 7 days after delivery after the completion of the first transfer ]
    The admittance of the newborn to NICU

  55. Admission to NICU [ Time Frame: 7 days after delivery, at 12 months after randomization ]
    The admittance of the newborn to NICU

  56. Genetic and epigenetic analysis of newborn [ Time Frame: 1 day (Prior to the initiation of IVF/IVM) and 1 day ( at the time of delivery) ]
    Maternal whole blood; newborn's materials including cord blood, neonatal buccal smear, and placental tissue will be collected. Data will be collected for a supplementary analysis and will be reported in a separated paper.

  57. Cost-effectiveness [ Time Frame: Two year after randomization ]
    Including direct and indirect costs; costs related to complications treatment. Cost data will be collected for a supplementary analysis and will be reported in a separated paper.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428919


Locations
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Vietnam
Dang Q Vinh
Hochiminh city, Vietnam
Sponsors and Collaborators
Mỹ Đức Hospital
An Sinh Hospital
Investigators
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Principal Investigator: Lan N Vuong, PhD University of Medicine and Pharmacy at Ho Chi Minh city
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mỹ Đức Hospital
ClinicalTrials.gov Identifier: NCT03428919    
Other Study ID Numbers: CS/MD/17/12
CS/AS/17/10 ( Other Identifier: An Sinh Hospital )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mỹ Đức Hospital:
ICSI
Conventional IVF
Non-male factor
Additional relevant MeSH terms:
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Infertility