Effects of Light vs. Heavy Paraffin Oil on Embryo Culture in IVF: A Prospective Study on Development and Pregnancy Rate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hung Vuong Hospital
- Enrollment
- 818
- Locations
- 1
- Primary Endpoint
- Fertilization Rate
Study Overview
Brief Summary
This prospective study aims to compare the effects of light and heavy paraffin oil in embryo culture during in vitro fertilization (IVF). Paraffin oil is commonly used in IVF laboratories to protect embryo culture media from evaporation and temperature fluctuations. However, the impact of different oil viscosities on embryo development and pregnancy outcomes remains unclear.
Participants undergoing IVF treatment will have their embryos cultured under either light or heavy paraffin oil conditions. The study will evaluate key outcomes, including embryo development, blastocyst formation rates, and pregnancy rates. Findings from this research may help optimize embryo culture conditions, potentially improving IVF success rates and guiding best laboratory practices.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women undergoing in vitro fertilization (IVF) treatment with planned embryo culture.
- •Patients with normal ovarian function or undergoing ovarian stimulation for IVF.
- •Willingness to participate and provide informed consent.
Exclusion Criteria
- •Presence of severe uterine abnormalities (e.g., congenital malformations, Asherman's syndrome).
- •History of recurrent implantation failure (≥3 unsuccessful IVF attempts).
- •Poor ovarian response (e.g., ≤3 oocytes retrieved in a previous IVF cycle).
- •Presence of severe male factor infertility, requiring testicular sperm extraction (TESE) or micro-TESE.
- •Use of pre-implantation genetic testing (PGT) for embryo selection.
- •Known autoimmune disorders or uncontrolled chronic conditions (e.g., diabetes, thyroid disorders) that may affect pregnancy outcomes.
- •Participation in another clinical trial that may interfere with study outcomes.
- •Donor cycles or surrogacy.
Arms & Interventions
Light Paraffin Oil Group
Embryos are cultured under light paraffin oil conditions.
Intervention: Light Paraffin Oil (Combination Product)
Heavy Paraffin Oil Group
Embryos are cultured under heavy paraffin oil conditions. Thus, the Number of Arms = 2.
Intervention: Heavy Paraffin Oil (Combination Product)
Outcomes
Primary Outcomes
Fertilization Rate
Time Frame: 16-20 hours post-insemination
The proportion of oocytes that successfully undergo fertilization after insemination, as determined by the presence of two pronuclei (2PN) at the appropriate time post-fertilization.
Cleavage Rate
Time Frame: 48 hours post-fertilization
The proportion of fertilized oocytes that progress to cleavage-stage embryos, assessed by the number of embryos that reach at least the two-cell stage within 48 hours after fertilization.
Blastocyst Formation Rate
Time Frame: 5-6 days post-fertilization
The proportion of embryos that successfully develop into blastocysts by Day 5 or Day 6 of culture, assessed based on morphological grading criteria.
Secondary Outcomes
- Clinical Pregnancy Rate(6-7 weeks post-embryo transfer)
- Ongoing Pregnancy Rate(12 weeks post-embryo transfer)
- Live Birth Rate(At delivery (up to ~40 weeks of gestation))
- Positive Beta-hCG(14 days post-embryo transfer)
- Pregnancy Loss Rate(From positive beta-hCG until delivery)
- Implantation Rate(4-5 weeks post-embryo transfer)
Investigators
Thi Thanh Thuy Tran, MD
Principal Investigator
Hung Vuong Hospital