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

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.

Study Overview

• Status: Completed
• Conditions: Embryo Development; IVF; Pregnancy Rates; Embryo Culture Media; Blastocyst IVF
• Intervention / Treatment: Combination product: Light Paraffin Oil; Combination product: Heavy Paraffin Oil

• Study Type: Interventional
• Enrollment (Actual): 818
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • Hung Vuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light Paraffin Oil Group; Embryos are cultured under light paraffin oil conditions.	Combination product: Light 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.
Experimental: Heavy Paraffin Oil Group; Embryos are cultured under heavy paraffin oil conditions. Thus, the Number of Arms = 2.	Combination product: Heavy 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hung Vuong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: February 16, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: heavy/light paraffin oil for embryo culture
• Additional Relevant MeSH Terms: Dermatologic Agents; Emollients; Mineral Oil
• Other Study ID Numbers: CS/HV/24/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No