Embryo DevelopmentNCT06838923
Effects of Light vs. Heavy Paraffin Oil on Embryo Culture in IVF: A Prospective Study on Development and Pregnancy Rate
A study testing Light Paraffin Oil and Heavy Paraffin Oil in people with Embryo Development and Blastocyst IVF, run by Hung Vuong Hospital at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo Development, Blastocyst IVF, Pregnancy Rates
- What is being tested?
- Light Paraffin Oil and Heavy Paraffin Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- 1 siteVietnam
- Study dates
- 23 May 2023to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Light Paraffin Oil, Heavy Paraffin Oil
- Keywords
- heavy/light paraffin oil for embryo culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Paraffin OilCombination 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 OilCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Light Paraffin Oil Group | Experimental | Embryos are cultured under light paraffin oil conditions. Receives: Combination Product: Light Paraffin Oil |
| Heavy Paraffin Oil Group | Experimental | Embryos are cultured under heavy paraffin oil conditions. Thus, the Number of Arms = 2. Receives: Combination Product: Heavy Paraffin Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5-6 days post-fertilization
Secondary outcomes (6)
Positive Beta-hCG
The proportion of participants achieving a positive serum beta-hCG test, indicating biochemical pregnancy, measured approximately two weeks after embryo transfer.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At delivery (up to ~40 weeks of gestation)
Pregnancy Loss Rate
The proportion of participants experiencing pregnancy loss at any stage
Measured: From positive beta-hCG until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start23 May 2023
- Primary completion31 Dec 2023
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hung Vuong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thi Thanh Thuy Tran, MD, Hung Vuong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838923
- Sponsor's protocol ID
- CS/HV/24/25
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Light vs. Heavy Paraffin Oil on Embryo Culture in IVF: A Prospective Study on Development and Pregnancy Rate
- ClinicalTrials.gov ID
- NCT06838923
- Acronym / sponsor ID
- CS/HV/24/25
- Conditions
- Embryo Development, Blastocyst IVF, Pregnancy Rates, IVF, Embryo Culture Media
- Keywords
- heavy/light paraffin oil for embryo culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- Hung Vuong HospitalUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Light Paraffin Oil Group | Experimental | Combination Product: Light Paraffin OilEmbryos are cultured under light paraffin oil conditions. |
| Heavy Paraffin Oil Group | Experimental | Combination Product: Heavy Paraffin OilEmbryos are cultured under heavy paraffin oil conditions. Thus, the Number of Arms = 2. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light Paraffin OilEmbryos 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. | Combination product | Light Paraffin Oil Group |
| Heavy Paraffin OilEmbryos 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. | Combination product | Heavy Paraffin Oil Group |
Primary outcome
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.
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.
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.
6 secondary outcomes
Positive Beta-hCG
Time frame: 14 days post-embryo transfer
Implantation Rate
Time frame: 4-5 weeks post-embryo transfer
Clinical Pregnancy Rate
Time frame: 6-7 weeks post-embryo transfer
Ongoing Pregnancy Rate
Time frame: 12 weeks post-embryo transfer
Live Birth Rate
Time frame: At delivery (up to ~40 weeks of gestation)
Pregnancy Loss Rate
Time frame: From positive beta-hCG until delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Paraffin Oil and Heavy Paraffin Oil in people with Embryo Development and Blastocyst IVF, run by Hung Vuong Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization Rate (time frame: 16-20 hours post-insemination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.