Effects of Light vs. Heavy Paraffin Oil on Embryo Culture in IVF: A Prospective Study on Development and Pregnancy Rate

Hung Vuong Hospital

Status: Completed

Conditions: Blastocyst IVF; Pregnancy Rates; IVF; Embryo Development; Embryo Culture Media

Treatments: Combination Product: Heavy Paraffin Oil; Combination Product: Light Paraffin Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06838923

CS/HV/24/25

Details and patient eligibility

About

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.

Enrollment: 818 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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818 participants in 2 patient groups

Light Paraffin Oil Group

Experimental group

Description:

Embryos are cultured under light paraffin oil conditions.

Treatment:

Combination Product: Light Paraffin Oil

Heavy Paraffin Oil Group

Experimental group

Description:

Embryos are cultured under heavy paraffin oil conditions. Thus, the Number of Arms = 2.

Treatment:

Combination Product: Heavy Paraffin Oil