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NCT Number: NCT06838923

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.

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Key information

Conditions

Embryo Development Blastocyst IVF Embryo Culture Media IVF Pregnancy Rates

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hung Vuong Hospital

Ho Chi Minh City, 700000, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Fertilization Rate

    Time frame: 16-20 hours post-insemination

    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.

  2. Cleavage Rate

    Time frame: 48 hours post-fertilization

    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.

  3. Blastocyst Formation Rate

    Time frame: 5-6 days post-fertilization

    The proportion of embryos that successfully develop into blastocysts by Day 5 or Day 6 of culture, assessed based on morphological grading criteria.

Secondary outcomes

  1. Positive Beta-hCG

    Time frame: 14 days post-embryo transfer

    The proportion of participants achieving a positive serum beta-hCG test, indicating biochemical pregnancy, measured approximately two weeks after embryo transfer.

  2. Implantation Rate

    Time frame: 4-5 weeks post-embryo transfer

    The proportion of transferred embryos that successfully implant in the uterus, determined by the presence of a gestational sac on ultrasound.

  3. Clinical Pregnancy Rate

    Time frame: 6-7 weeks post-embryo transfer

    The proportion of participants with ultrasound-confirmed pregnancy, defined by the presence of a gestational sac with fetal heartbeat.

  4. Ongoing Pregnancy Rate

    Time frame: 12 weeks post-embryo transfer

    The proportion of participants with a viable pregnancy continuing beyond the first trimester (≥12 weeks of gestation).

  5. Live Birth Rate

    Time frame: At delivery (up to ~40 weeks of gestation)

    The proportion of participants who achieve a live birth, defined as the delivery of a viable infant at ≥24 weeks of gestation.

  6. Pregnancy Loss Rate

    Time frame: From positive beta-hCG until delivery

    The proportion of participants experiencing pregnancy loss at any stage

Sponsors and collaborators

Lead sponsor

Hung Vuong Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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