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

NCT ID: NCT06838923

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

818 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2025-01-15

Brief Summary

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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

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Conditions

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Embryo Development Blastocyst IVF Pregnancy Rates IVF Embryo Culture Media

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Light Paraffin Oil Group

Embryos are cultured under light paraffin oil conditions.

Group Type EXPERIMENTAL

Light Paraffin Oil

Intervention Type 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 Group

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

Group Type EXPERIMENTAL

Heavy Paraffin Oil

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hung Vuong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thi Thanh Thuy Tran, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hung Vuong Hospital

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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CS/HV/24/25

Identifier Type: -

Identifier Source: org_study_id

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