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

Not Applicable

Completed

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

• Registration Number: NCT06838923
• Lead Sponsor: Hung Vuong Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-23
• Primary Completion: 2023-12-31
• Study Completion: 2025-01-15
• Status Verified: 2025-02
• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 818

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fertilization Rate	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.
Cleavage Rate	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.
Blastocyst Formation Rate	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 Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	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.
Ongoing Pregnancy Rate	12 weeks post-embryo transfer	The proportion of participants with a viable pregnancy continuing beyond the first trimester (≥12 weeks of gestation).
Live Birth Rate	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.
Positive Beta-hCG	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.
Pregnancy Loss Rate	From positive beta-hCG until delivery	The proportion of participants experiencing pregnancy loss at any stage
Implantation Rate	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.

Trial Locations

Locations (1)

Hung Vuong Hospital; 🇻🇳 Ho Chi Minh City, Vietnam