Infertility Clinical Trial
Official title:
The Effectiveness of a Freeze All Protocol Versus Fresh Embryo Transfer in Women Undergoing In-vitro Fertilization (IVF) - Intracytoplasmic Sperm Injection (ICSI)
Verified date | September 2017 |
Source | Vietnam National University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the effectiveness of freeze-all and subsequent frozen embryo transfer (freeze all protocol) with fresh embryo transfer (fresh ET).
Status | Completed |
Enrollment | 782 |
Est. completion date | February 1, 2017 |
Est. primary completion date | April 10, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | My Duc Hospital, IVFMD | Ho Chi Minh City | Ho Chi Minh |
Lead Sponsor | Collaborator |
---|---|
Vietnam National University | M? Ð?c Hospital |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Ovarian hyperstimulation syndrome (OHSS) | Symptoms of OHSS | at 10 days after hCG injection and 14 days after embryo transfer | |
Other | Miscarriage | complete lost of clinical pregnancy | at 24 weeks of gestation | |
Other | Ectopic pregnancy | ectopic nidation of a pregnancy confirmed by sonography or laparoscopy | at 12 weeks of gestation | |
Other | Live birth | birth of a newborn with any sign of life | at birth | |
Other | Gestational age at delivery | gestational age at delivery | at the time of delivery | |
Other | Birth weight | Weight of newborn | at the time of delivery | |
Other | congenital malformation | congenital malformation of newborn | at the time of delivery | |
Other | Macrosomia | Birth weight > 90th percentile | at the time of delivery | |
Other | small for gestational age | birth weight < 10th percentile | at the time of delivery | |
Other | NICU admittance | The admittance of the newborn to NICU | 7 days after delivery | |
Other | Pregnancy-associated hypertension | 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. | at 20 weeks of gestation | |
Other | Preeclampsia | 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]) | at 20 weeks of gestation | |
Other | HELLP syndrome | 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) | at 20 weeks of gestation | |
Other | Prematurity | Preterm birth | at 32 weeks and 37 weeks of gestation | |
Other | antepartum hemorrhage | bleeding from the genital tract | in the second half of pregnancy | |
Other | Gestational diabetes mellitus | using a 75g oral glucose tolerance test | at 24 weeks of gestation | |
Other | Mode of deliver | Normal delivery, vaginal instrument delivery or Cesarean section | at the time of delivery | |
Other | Permpartum increased blood loss | Blood loss more than 1000ml | 24 hours after delivery | |
Primary | Ongoing pregnancy | Ongoing pregnancy is defined as a pregnancy with at least one positive heart beat beyond 12 weeks of gestation. | 12 weeks of gestation | |
Secondary | Clinical pregnancy | Clinical pregnancy is explained as the presence of a gestational sac seen by transvaginal sonography. | 5 weeks after embryo placement | |
Secondary | Implantation rate | Implantation rate is explained as as the number of gestational sacs per number of embryos transferred. | 3 weeks after embryo transferred | |
Secondary | Multiple pregnancy rate | Multiple pregnancy is explained as two or more gestational sacs or positive heart beats by transvaginal sonography. | 5 weeks after embryo placement | |
Secondary | Live birth | Live birth is defined if a live newborn delivered. | at the time of delivery |
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