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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light Paraffin Oil Group | Experimental | Embryos are cultured under light paraffin oil conditions. |
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| Heavy Paraffin Oil Group | Experimental | Embryos are cultured under heavy paraffin oil conditions. Thus, the Number of Arms = 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Paraffin Oil | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization Rate | 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. | 16-20 hours post-insemination |
| Cleavage Rate | 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. | 48 hours post-fertilization |
| Blastocyst Formation Rate | The proportion of embryos that successfully develop into blastocysts by Day 5 or Day 6 of culture, assessed based on morphological grading criteria. | 5-6 days post-fertilization |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Beta-hCG | The proportion of participants achieving a positive serum beta-hCG test, indicating biochemical pregnancy, measured approximately two weeks after embryo transfer. | 14 days post-embryo transfer |
| Implantation Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hung Vuong Hospital | Ho Chi Minh City | 700000 | Vietnam |
Individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and privacy, in accordance with ethical guidelines and regulatory requirements for fertility treatment studies. Additionally, since this study involves sensitive reproductive health data, data sharing is restricted to aggregate-level results to protect participant anonymity.
However, summary findings and statistical analyses will be made available through peer-reviewed publications and conference presentations to ensure transparency and contribution to scientific knowledge.
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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.
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| Heavy Paraffin Oil | Combination Product | 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. |
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The proportion of transferred embryos that successfully implant in the uterus, determined by the presence of a gestational sac on ultrasound.
| 4-5 weeks post-embryo transfer |
| Clinical Pregnancy Rate | The proportion of participants with ultrasound-confirmed pregnancy, defined by the presence of a gestational sac with fetal heartbeat. | 6-7 weeks post-embryo transfer |
| Ongoing Pregnancy Rate | The proportion of participants with a viable pregnancy continuing beyond the first trimester (≥12 weeks of gestation). | 12 weeks post-embryo transfer |
| Live Birth Rate | The proportion of participants who achieve a live birth, defined as the delivery of a viable infant at ≥24 weeks of gestation. | At delivery (up to ~40 weeks of gestation) |
| Pregnancy Loss Rate | The proportion of participants experiencing pregnancy loss at any stage | From positive beta-hCG until delivery |