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Freeze All Protocol Versus Fresh Embryo Transfer in Women Undergoing In-vitro Fertilization (IVF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471573
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : September 7, 2017
Sponsor:
Collaborator:
Mỹ Đức Hospital
Information provided by (Responsible Party):
Manh Tuong Ho, Vietnam National University

Brief Summary:
To compare the effectiveness of freeze-all and subsequent frozen embryo transfer (freeze all protocol) with fresh embryo transfer (fresh ET).

Condition or disease Intervention/treatment Phase
Infertility Procedure: Freeze-all protocol Procedure: Fresh transfer protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 782 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of a Freeze All Protocol Versus Fresh Embryo Transfer in Women Undergoing In-vitro Fertilization (IVF) - Intracytoplasmic Sperm Injection (ICSI)
Actual Study Start Date : June 30, 2015
Actual Primary Completion Date : April 10, 2016
Actual Study Completion Date : February 1, 2017

Arm Intervention/treatment
Active Comparator: Freeze-all protocol
Embryos are selected for cryopreservation using vitrification technique. Two vitrified embryos will be warmed and transferred in subsequent cycle.
Procedure: Freeze-all protocol
Embryos are selected for cryopreservation using vitrification technique. Two vitrified embryos will be warmed and transferred in subsequent cycle.

Active Comparator: Fresh transfer protocol
Two embryos are selected and transferred fresh in the same cycle.
Procedure: Fresh transfer protocol
Two embryos are selected and transferred fresh in the same cycle.




Primary Outcome Measures :
  1. Ongoing pregnancy [ Time Frame: 12 weeks of gestation ]
    Ongoing pregnancy is defined as a pregnancy with at least one positive heart beat beyond 12 weeks of gestation.


Secondary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 5 weeks after embryo placement ]
    Clinical pregnancy is explained as the presence of a gestational sac seen by transvaginal sonography.

  2. Implantation rate [ Time Frame: 3 weeks after embryo transferred ]
    Implantation rate is explained as as the number of gestational sacs per number of embryos transferred.

  3. 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.

  4. Live birth [ Time Frame: at the time of delivery ]
    Live birth is defined if a live newborn delivered.


Other Outcome Measures:
  1. Ovarian hyperstimulation syndrome (OHSS) [ Time Frame: at 10 days after hCG injection and 14 days after embryo transfer ]
    Symptoms of OHSS

  2. Miscarriage [ Time Frame: at 24 weeks of gestation ]
    complete lost of clinical pregnancy

  3. Ectopic pregnancy [ Time Frame: at 12 weeks of gestation ]
    ectopic nidation of a pregnancy confirmed by sonography or laparoscopy

  4. Live birth [ Time Frame: at birth ]
    birth of a newborn with any sign of life

  5. Gestational age at delivery [ Time Frame: at the time of delivery ]
    gestational age at delivery

  6. Birth weight [ Time Frame: at the time of delivery ]
    Weight of newborn

  7. congenital malformation [ Time Frame: at the time of delivery ]
    congenital malformation of newborn

  8. Macrosomia [ Time Frame: at the time of delivery ]
    Birth weight > 90th percentile

  9. small for gestational age [ Time Frame: at the time of delivery ]
    birth weight < 10th percentile

  10. NICU admittance [ Time Frame: 7 days after delivery ]
    The admittance of the newborn to NICU

  11. Pregnancy-associated hypertension [ Time Frame: at 20 weeks of gestation ]
    systolic blood pressure of ≥140 mmHg or diastolic pressure of ≥90 mmHg on two occasions 2 hours apart, or a severely elevated single blood pressure measurement that led to treatment with an antihypertensive medication.

  12. Preeclampsia [ Time Frame: at 20 weeks of gestation ]
    any type of hypertension combined with proteinuria (total protein excretion of 300 mg or other organ involvement [such as renal insufficiency, liver involvement, neurological or hematological complications, uteroplacental dysfunction, or fetal growth restriction])

  13. HELLP syndrome [ Time Frame: at 20 weeks of gestation ]
    elevated liver enzyme levels (aspartate aminotransferase ≥100 U/L), thrombocytopenia (platelet count <100,000/mm3), elevated serum creatinine level (≥1.5 mg/dL [132.6 μmol/L]) and/or hemolysis (hemoglobin <10 g/dL)

  14. Prematurity [ Time Frame: at 32 weeks and 37 weeks of gestation ]
    Preterm birth

  15. antepartum hemorrhage [ Time Frame: in the second half of pregnancy ]
    bleeding from the genital tract

  16. Gestational diabetes mellitus [ Time Frame: at 24 weeks of gestation ]
    using a 75g oral glucose tolerance test

  17. Mode of deliver [ Time Frame: at the time of delivery ]
    Normal delivery, vaginal instrument delivery or Cesarean section

  18. Permpartum increased blood loss [ Time Frame: 24 hours after delivery ]
    Blood loss more than 1000ml



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing In-vitro fertilization (IVF) treatment
  • Number of previous failed embryo transfers ≤ 2
  • Permanent living in Viet Nam
  • Ovarian hyperstimulation with Gonadotropin releasing hormone (GnRH) antagonist protocol
  • Eligible for embryo transfer (ET) on day 3
  • Having at least one top-quality embryo on day 3.
  • Number of embryos transferred ≤ 2
  • Willing to participate in the study
  • Not to participate in another IVF study at the same time

Exclusion Criteria:

  • women with polycystic ovary syndrome
  • In vitro maturation (IVM) cycles
  • Oocyte donation cycles
  • Using GnRH agonist for triggering

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): NCT02471573


Locations
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Vietnam
My Duc Hospital, IVFMD
Ho Chi Minh City, Ho Chi Minh, Vietnam
Sponsors and Collaborators
Vietnam National University
Mỹ Đức Hospital
Investigators
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Study Chair: Tuong M Ho, MD Research Center for Genetics and Reproductive Health, School of Medicine, Vietnam National University HCMC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manh Tuong Ho, Doctor, Vietnam National University
ClinicalTrials.gov Identifier: NCT02471573    
Other Study ID Numbers: NCKH/CGRH_ 03_2015
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Manh Tuong Ho, Vietnam National University:
IVF
Freeze-all
frozen embryo transfer
fresh transfer
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female