Blastocyst IVF, Embryo Culture Media, Embryo Development, IVF, Pregnancy Rates
Conditions
Keywords
heavy/light paraffin oil for embryo culture
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.
Interventions
COMBINATION_PRODUCTLight Paraffin Oil
Embryos in this group will be cultured under conditions using light paraffin oil as an overlay in in vitro fertilization (IVF). The oil serves to protect the culture media from evaporation and temperature fluctuations. Key outcomes, including embryo development, blastocyst formation rate, and pregnancy rate, will be assessed.
COMBINATION_PRODUCTHeavy Paraffin Oil
Embryos in this group will be cultured under conditions using heavy paraffin oil as an overlay in in vitro fertilization (IVF). This study aims to compare the effects of heavy paraffin oil to light paraffin oil in embryo culture, assessing embryo development, blastocyst formation, and pregnancy rates.
Sponsors
Hung Vuong Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study employs a parallel assignment model, where participants undergoing in vitro fertilization (IVF) are randomly assigned to one of two groups. In the light paraffin oil group, embryos are cultured under conditions using light paraffin oil, while in the heavy paraffin oil group, embryos are cultured using heavy paraffin oil. The study aims to compare the effects of these two oil types on embryo development and pregnancy outcomes. Participants remain in their assigned group throughout the study without crossover between interventions. Key outcomes, including embryo development, blastocyst formation rate, and pregnancy rate, will be evaluated to determine which oil type provides optimal conditions for embryo culture in IVF.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fertilization Rate | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Ongoing Pregnancy Rate | 12 weeks post-embryo transfer | The proportion of participants with a viable pregnancy continuing beyond the first trimester (≥12 weeks of gestation). |
| Positive Beta-hCG | 14 days post-embryo transfer | The proportion of participants achieving a positive serum beta-hCG test, indicating biochemical pregnancy, measured approximately two weeks after embryo transfer. |
| Pregnancy Loss Rate | From positive beta-hCG until delivery | The proportion of participants experiencing pregnancy loss at any stage |
| Live Birth Rate | At delivery (up to ~40 weeks of gestation) | The proportion of participants who achieve a live birth, defined as the delivery of a viable infant at ≥24 weeks of gestation. |
| Implantation Rate | 4-5 weeks post-embryo transfer | The proportion of transferred embryos that successfully implant in the uterus, determined by the presence of a gestational sac on ultrasound. |
| Clinical Pregnancy Rate | 6-7 weeks post-embryo transfer | The proportion of participants with ultrasound-confirmed pregnancy, defined by the presence of a gestational sac with fetal heartbeat. |
Countries
Vietnam
Outcome results
None listed