Clinical trial NCT06838923: Effects of Light vs. Heavy Paraffin Oil on Embryo Culture in IVF: A Prospective Study on Development and Pregnancy Rate
Official title: Effects of Light vs. Heavy Paraffin Oil on Embryo Culture in IVF: A Prospective Study on Development and Pregnancy Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Development
Blastocyst IVF
Pregnancy Rates
IVF
Embryo Culture Media
Keywords: heavy/light paraffin oil for embryo culture
Lead sponsor: Hung Vuong Hospital
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 818
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fertilization Rate
timeFrame: 16-20 hours post-insemination
measure: Cleavage Rate
timeFrame: 48 hours post-fertilization
measure: Blastocyst Formation Rate
timeFrame: 5-6 days post-fertilization
Secondary outcomes:
measure: Positive Beta-hCG
timeFrame: 14 days post-embryo transfer
measure: Implantation Rate
timeFrame: 4-5 weeks post-embryo transfer
measure: Clinical Pregnancy Rate
timeFrame: 6-7 weeks post-embryo transfer
measure: Ongoing Pregnancy Rate
timeFrame: 12 weeks post-embryo transfer
measure: Live Birth Rate
timeFrame: At delivery (up to ~40 weeks of gestation)
measure: Pregnancy Loss Rate
timeFrame: From positive beta-hCG until delivery
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Hung Vuong Hospital
Study officials:
References: