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ICSI Versus Conventional IVF in Non-male Factor Couples

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ClinicalTrials.gov Identifier: NCT03428919
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : April 9, 2018
Sponsor:
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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated 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 Couple With Non-male Factor Infertility
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : June 2, 2020
Estimated Study Completion Date : December 2, 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 undergoing IVF/ICSI will be treated with a GnRH antagonist protocol. Criteria for hCG (6,500 IU) using will be the presence of at least three 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 under inverted microscope 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 undergoing IVF/ICSI will be treated with a GnRH antagonist protocol. Criteria for hCG (6,500 IU) using will be the presence of at least three 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, at a concentration of 100,000 motile sperm/ml. Inseminated OCCs will be cultured overnight in culture medium.

Fertilization check will be performed under inverted microscope 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: 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 obtained from all the embryos from the first 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 [ Time Frame: At 18-20h after inseminated/injected ]
    Fertilization is defined as the appearance of 2 PN

  2. Abnormal fertilization rate [ Time Frame: At 18-20h after inseminated/injected ]
    Abnormal fertilization is defined as the appearance of 3 PN

  3. Total fertilization failure rate [ Time Frame: At 18-20h after inseminated/injected ]
    Total fertilization is defined as the absence of any zygotes with 2PN

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

  5. 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

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

  7. Ongoing pregnancy resulting in live birth from the first embryo transfer of the started treatment cycle. [ Time Frame: 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).

  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. 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

  11. 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

  12. Number of freezable embryos [ Time Frame: 3 days after oocytes pick-up day in IVF/ICSI ]
    Number of freezable embryos is defined as the number of embryos freezing after the completion of the first transfer

  13. Cumulative ongoing pregnancy at 12 months [ Time Frame: 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.

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

  15. Ectopic pregnancy [ Time Frame: At 12 weeks of gestation ]
    Ectopic nidation of a pregnancy confirmed by sonography or laparoscopy

  16. Miscarriage [ Time Frame: At 24 weeks of gestation ]
    Complete lost of clinical pregnancy

  17. Multiple pregnancy rate [ Time Frame: 5 weeks after embryo placement ]
    Multiple pregnancy is explained as two or more gestational sacs or positive heart beats by transvaginal sonography.

  18. Multiple delivery [ Time Frame: At birth ]
    Multiple delivery is defined as birth of more than one baby beyond 24 weeks

  19. Gestational age at delivery [ Time Frame: At birth ]
    Gestational age at delivery

  20. Hypertensive disorders of pregnancy [ Time Frame: At birth ]
    Hypertensive disorders of pregnancy will include pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia)

  21. Antepartum haemorrhage [ Time Frame: At birth ]
    Antepartum haemorrhage will include placenta previa, placenta accreta and unexplained

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

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

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

  25. Birth weight [ Time Frame: At birth ]
    Weight of newborn

  26. Low birth weight [ Time Frame: At birth ]
    Low birth weight is defined as <2500 gm

  27. Very low birth weight [ Time Frame: At birth ]
    Very low birth weight is defined as <1500 gm

  28. High birth weight [ Time Frame: At birth ]
    High birth weight is defined as >4000 gm

  29. Very high birth weight [ Time Frame: At birth ]
    Very high birth weight is defined as >4500 gm

  30. Large for gestational age [ Time Frame: At birth ]
    Large for gestational age is defined as birth weight >90th percentile

  31. Small for gestational age [ Time Frame: At birth ]
    Small for gestational age is defined as birth weight <10th percentile

  32. Congenital anomaly diagnosed at birth [ Time Frame: At birth ]
    Any congenital anomaly will be included

  33. Admission to NICU [ Time Frame: At 7 days after birth ]
    The admittance of the newborn to NICU



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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:

  • Indications for IVF treatment with non-male factor
  • Having ≤ 2 IVF/ICSI cycles
  • Ovarian stimulation with FSH/GnRH antagonist protocol
  • Sperm count and motility are normal (WHO, 2010)
  • Agree to have ≤ 2 embryos transferred
  • Not participating in another IVF study at the same time

Exclusion Criteria:

  • In-vitro maturation (IVM) cycles
  • PCOS
  • Agonist trigger
  • 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


Contacts
Contact: Vinh Q Dang, MD +84908225481 BSVINH.DQ@MYDUCHOSPITAL.VN
Contact: Quynh N Nguyen, BSc +84933310693 quynh.nn@myduchospital.vn

Locations
Vietnam
Dang Q Vinh Recruiting
Hochiminh city, Vietnam
Contact: Vinh Q Dang, MD    +84908225481    BSVINH.DQ@MYDUCHOSPITAL.VN   
Contact: Quynh N Nguyen, BSc    +84933310693    quynh.nn@myduchospital.vn   
Sponsors and Collaborators
Mỹ Đức Hospital
Investigators
Principal Investigator: Lan N Vuong, PhD University of Medicine and Pharmacy at Ho Chi Minh city

Responsible Party: Mỹ Đức Hospital
ClinicalTrials.gov Identifier: NCT03428919     History of Changes
Other Study ID Numbers: CS/MD/17/12
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Infertility
Genital Diseases, Male
Genital Diseases, Female