Infertility Clinical Trial
Official title:
The Effectiveness of Intracytoplasmic Sperm Injection Versus Conventional in Vitro Fertilization in Couples With Non-male Factor Infertility: a Randomized Controlled Trial
Verified date | October 2020 |
Source | M? Ð?c Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1064 |
Est. completion date | August 12, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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%) |
Country | Name | City | State |
---|---|---|---|
Vietnam | Dang Q Vinh | Hochiminh city |
Lead Sponsor | Collaborator |
---|---|
M? Ð?c Hospital | An Sinh Hospital |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Fertilization rate per oocyte inseminated/injected | Fertilization is defined as the appearance of 2 PN | At 16-18 hours after injected or 17-19 hours after inseminated | |
Secondary | Fertilization rate per oocyte retrieved | Fertilization is defined as the appearance of 2 PN | At 16-18 hours after injected or 17-19 hours after inseminated | |
Secondary | Abnormal fertilization rate | Abnormal fertilization is defined as the appearance of 1PN or =3 PN | At 16-18 hours after injected or 17-19 hours after inseminated | |
Secondary | Total fertilization failure rate | Total fertilization is defined as the absence of any zygotes with 2PN | At 16-18 hours after injected or 17-19 hours after inseminated | |
Secondary | Number of embryos on day 3 | Number of embryos on day 3 | 3 days after oocytes pick-up day in IVF/ICSI | |
Secondary | Number of good quality embryo on day 3 | Numbers of embryos on day 3 with good quality | 3 days after oocytes pick-up day in IVF/ICSI | |
Secondary | Number of embryo freezing on day 3 | Number of embryos freezing on day 3 | 3 days after oocytes pick-up day in IVF/ICSI | |
Secondary | Positive pregnancy test | Positive pregnancy test is defined as a serum human chorionic gonadotropin level greater than 25 mIU/mL after the completion of the first transfer | 14 days after embryo transfer | |
Secondary | Clinical pregnancy | 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 | At 7 weeks' gestation | |
Secondary | Implantation rate | Implantation rate is defined as the number of gestational sacs per number of embryos transferred after the completion of the first transfer | At 3 weeks after embryo transferred | |
Secondary | Ongoing pregnancy | Ongoing pregnancy is defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after the completion of the first transfer | At 12 weeks' gestation | |
Secondary | Cumulative ongoing pregnancy | 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. | 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. | |
Secondary | Ongoing pregnancy resulting in live birth obtained from all embryos from the first 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). | 12 weeks of gestation at 12 months after randomization | |
Secondary | Time from randomization to ongoing pregnancy | Time from randomization to ongoing pregnancy after the completion of the first transfer | 12 weeks of gestation after the completion of first transfer | |
Secondary | Ovarian hyperstimulation syndrome (OHSS) | Symptoms of OHSS | At 10 days after hCG injection and 14 days after embryo transfer | |
Secondary | Ectopic pregnancy | A pregnancy in which implantation takes place outside the uterine cavity after completion of the first transfer | At 12 weeks of gestation after the completion of the first transfer | |
Secondary | Ectopic pregnancy | A pregnancy in which implantation takes place outside the uterine cavity after transfer of all embryos from the started treatment cycle. | At 12 weeks of gestation at 12 months after randomization. | |
Secondary | Miscarriage | The loss of a clinical pregnancy at 24 weeks of gestation after the completion of the first transfer | At 24 weeks of gestation after the completion of the first transfer | |
Secondary | Miscarriage | The loss of a clinical pregnancy at 24 weeks of gestation after the completion transfer of all embryos from the started treatment cycle | At 24 weeks of gestation at 12 months after the randomization. | |
Secondary | Multiple pregnancy | Multiple pregnancy is explained as two or more gestational sacs or positive heart beats by transvaginal sonography, after the completion of the first transfer | 7 weeks' gestation after the completion of the first transfer | |
Secondary | Multiple pregnancy | 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 | 7 weeks' gestation at 12 months after randomization | |
Secondary | Multiple delivery | Multiple delivery is defined as birth of more than one baby beyond 24 weeks, after the completion of the first transfer | At birth, after the completion of the first transfer | |
Secondary | Multiple delivery | 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 | At birth at 12 months after randomization | |
Secondary | Gestational diabetes mellitus | Development of diabetes during pregnancy | At 24 weeks of gestation after the completion of the first transfer | |
Secondary | Gestational diabetes mellitus | Development of diabetes during pregnancy | At 24 weeks of gestation at 12 months after randomization | |
Secondary | Hypertensive disorders of pregnancy | Hypertensive disorders of pregnancy will include pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia) | From 20 weeks of gestation up to at birth after the completion of the first transfer | |
Secondary | Hypertensive disorders of pregnancy | Hypertensive disorders of pregnancy will include pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia) | From 20 weeks of gestation up to at birth at 12 months after randomization | |
Secondary | Antepartum haemorrhage | Including placenta previa, placenta accreta and unexplained | From 20 weeks of gestation up to at birth, after the completion of the first transfer | |
Secondary | Antepartum haemorrhage | Including placenta previa, placenta accreta and unexplained | From 20 weeks of gestation up to at birth, at 12 months after randomization | |
Secondary | Gestational age at delivery | Gestational age at delivery | At birth, after the completion of the first transfer | |
Secondary | Gestational age at delivery | Gestational age at delivery | At birth, at 12 months after randomization | |
Secondary | Preterm delivery | Preterm delivery is defined as any delivery at <24, <28, <32, <37 completed weeks' gestation | At birth, after the completion of the first transfer | |
Secondary | Preterm delivery | Preterm delivery is defined as any delivery at <24, <28, <32, <37 completed weeks' gestation | At birth, at 12 months after randomization | |
Secondary | Spontaneous preterm birth | Spontaneous preterm birth is defined as delivery spontaneously at <24, <28, <32, <37 completed weeks | At birth, after the completion of the first transfer | |
Secondary | Spontaneous preterm birth | Spontaneous preterm birth is defined as delivery spontaneously at <24, <28, <32, <37 completed weeks | At birth, at 12 months after randomization | |
Secondary | Iatrogenic preterm birth | Iatrogenic preterm birth is defined as delivery non-spontaneously at <24, <28, <32, <37 completed weeks | At birth, after the completion of the first transfer | |
Secondary | Iatrogenic preterm birth | Iatrogenic preterm birth is defined as delivery non-spontaneously at <24, <28, <32, <37 completed weeks | At birth, at 12 months after randomization | |
Secondary | Birth weight | Weight of newborn | At birth, after the completion of the first transfer | |
Secondary | Birth weight | Weight of newborn | At birth, at 12 months after randomization | |
Secondary | Low birth weight | Low birth weight is defined as <2500 gm | At birth, after the completion of the first transfer | |
Secondary | Low birth weight | Low birth weight is defined as <2500 gm | At birth, at 12 months after randomization | |
Secondary | Very low birth weight | Very low birth weight is defined as <1500 gm | At birth, after the completion of the first transfer | |
Secondary | Very low birth weight | Very low birth weight is defined as <1500 gm | At birth, at 12 months after randomization | |
Secondary | High birth weight | High birth weight is defined as >4000 gm | At birth, after the completion of the first transfer | |
Secondary | High birth weight | High birth weight is defined as >4000 gm | At birth, at 12 months after randomization | |
Secondary | Very high birth weight | Very high birth weight is defined as >4500 gm | At birth, after the completion of the first transfer | |
Secondary | Very high birth weight | Very high birth weight is defined as >4500 gm | At birth, at 12 months after randomization | |
Secondary | Large for gestational age | Large for gestational age is defined as birth weight >90th percentile | At birth, after the completion of the first transfer | |
Secondary | Large for gestational age | Large for gestational age is defined as birth weight >90th percentile | At birth, at 12 months after randomization | |
Secondary | Small for gestational age | Small for gestational age is defined as birth weight <10th percentile | At birth, after the completion of the first transfer | |
Secondary | Small for gestational age | Small for gestational age is defined as birth weight <10th percentile | At birth, at 12 months after randomization | |
Secondary | Congenital anomaly diagnosed at birth | Any congenital anomaly will be included | At birth, after the completion of the first transfer | |
Secondary | Congenital anomaly diagnosed at birth | Any congenital anomaly will be included | At birth, at 12 months after randomization | |
Secondary | Admission to NICU | The admittance of the newborn to NICU | 7 days after delivery after the completion of the first transfer | |
Secondary | Admission to NICU | The admittance of the newborn to NICU | 7 days after delivery, at 12 months after randomization | |
Secondary | Genetic and epigenetic analysis of newborn | 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. | 1 day (Prior to the initiation of IVF/IVM) and 1 day ( at the time of delivery) | |
Secondary | Cost-effectiveness | 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. | Two year after randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A |