ICSI Versus Conventional IVF in Non-male Factor Couples

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03428919
• Date of registration: 02/02/2018
• Prospective Registration: Yes
• Primary sponsor: M? Ð?c Hospital
• Public title: ICSI Versus Conventional IVF in Non-male Factor Couples
• Scientific title: The Effectiveness of Intracytoplasmic Sperm Injection Versus Conventional in Vitro Fertilization in Couples With Non-male Factor Infertility: a Randomized Controlled Trial
• Date of first enrolment: March 16, 2018
• Target sample size: 1064
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03428919
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Vietnam

Contacts

• Name: Lan N Vuong, PhD
• Affiliation: University of Medicine and Pharmacy at Ho Chi Minh city

Key inclusion & exclusion 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%)



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility

Intervention(s)

Procedure: ICSI

Procedure: IVF

Primary Outcome(s)

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

Secondary Outcome(s)

Ectopic pregnancy [Time Frame: At 12 weeks of gestation at 12 months after randomization.]

Low birth weight [Time Frame: At birth, at 12 months after randomization]

Very high birth weight [Time Frame: At birth, at 12 months after randomization]

Very low birth weight [Time Frame: At birth, after the completion of the first transfer]

Admission to NICU [Time Frame: 7 days after delivery, at 12 months after randomization]

High birth weight [Time Frame: At birth, after the completion of the first transfer]

Iatrogenic preterm birth [Time Frame: At birth, after the completion of the first transfer]

Large for gestational age [Time Frame: At birth, at 12 months after randomization]

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

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

Preterm delivery [Time Frame: At birth, at 12 months after randomization]

Spontaneous preterm birth [Time Frame: At birth, at 12 months after randomization]

Clinical pregnancy [Time Frame: At 7 weeks' gestation]

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.]

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)]

Admission to NICU [Time Frame: 7 days after delivery after the completion of the first transfer]

High birth weight [Time Frame: At birth, at 12 months after randomization]

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

Small for gestational age [Time Frame: At birth, after the completion of the first transfer]

Large for gestational age [Time Frame: At birth, after the completion of the first transfer]

Miscarriage [Time Frame: At 24 weeks of gestation after the completion of the first transfer]

Fertilization rate per oocyte inseminated/injected [Time Frame: At 16-18 hours after injected or 17-19 hours after inseminated]

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

Cost-effectiveness [Time Frame: Two year after randomization]

Antepartum haemorrhage [Time Frame: From 20 weeks of gestation up to at birth, after the completion of the first transfer]

Small for gestational age [Time Frame: At birth, at 12 months after randomization]

Antepartum haemorrhage [Time Frame: From 20 weeks of gestation up to at birth, at 12 months after randomization]

Birth weight [Time Frame: At birth, at 12 months after randomization]

Miscarriage [Time Frame: At 24 weeks of gestation at 12 months after the randomization.]

Congenital anomaly diagnosed at birth [Time Frame: At birth, after the completion of the first transfer]

Fertilization rate per oocyte retrieved [Time Frame: At 16-18 hours after injected or 17-19 hours after inseminated]

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

Low birth weight [Time Frame: At birth, after the completion of the first transfer]

Multiple delivery [Time Frame: At birth, after the completion of the first transfer]

Multiple pregnancy [Time Frame: 7 weeks' gestation after the completion of the first transfer]

Multiple delivery [Time Frame: At birth at 12 months after randomization]

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

Gestational diabetes mellitus [Time Frame: At 24 weeks of gestation at 12 months after randomization]

Hypertensive disorders of pregnancy [Time Frame: From 20 weeks of gestation up to at birth after the completion of the first transfer]

Implantation rate [Time Frame: At 3 weeks after embryo transferred]

Multiple pregnancy [Time Frame: 7 weeks' gestation at 12 months after randomization]

Ongoing pregnancy [Time Frame: At 12 weeks' gestation]

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]

Total fertilization failure rate [Time Frame: At 16-18 hours after injected or 17-19 hours after inseminated]

Very high birth weight [Time Frame: At birth, after the completion of the first transfer]

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

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

Very low birth weight [Time Frame: At birth, at 12 months after randomization]

Abnormal fertilization rate [Time Frame: At 16-18 hours after injected or 17-19 hours after inseminated]

Congenital anomaly diagnosed at birth [Time Frame: At birth, at 12 months after randomization]

Ectopic pregnancy [Time Frame: At 12 weeks of gestation after the completion of the first transfer]

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

Hypertensive disorders of pregnancy [Time Frame: From 20 weeks of gestation up to at birth at 12 months after randomization]

Iatrogenic preterm birth [Time Frame: At birth, at 12 months after randomization]

Positive pregnancy test [Time Frame: 14 days after embryo transfer]

Preterm delivery [Time Frame: At birth, after the completion of the first transfer]

Spontaneous preterm birth [Time Frame: At birth, after the completion of the first transfer]

Secondary ID(s)

CS/MD/17/12

CS/AS/17/10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

An Sinh Hospital