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

NCT06838923 | Completed

• 1 other identifier: CS/HV/24/25
• Study Type: interventional
• Target: 818
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

heavy/light paraffin oil for embryo culture

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Positive Beta-hCG

  14 days post-embryo transfer

• Implantation Rate

  4-5 weeks post-embryo transfer

• 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)

Study Arms (2)

Light Paraffin Oil Group

EXPERIMENTAL

Embryos are cultured under light paraffin oil conditions.

Combination Product: Light Paraffin Oil

Heavy Paraffin Oil Group

EXPERIMENTAL

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

Combination Product: Heavy Paraffin Oil

Interventions

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.

Light Paraffin Oil Group

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.

Heavy Paraffin Oil Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hung Vuong Hospital: lead

Study Sites (1)

Hung Vuong Hospital

Ho Chi Minh City, 700000, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 21, 2025
• Study Start: May 23, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 15, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)