Extended Culture of Day 3 to Day 5 Frozen Thawed Day 3 Embryos Versus Day 5 Frozen-Thawed Embryos

NCT ID: NCT05858333

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-12-01

Brief Summary

Cryopreservation of embryos and oocytes has become routine in assisted reproduction technology (ART). Live birth rates following frozen embryo transfers have increased significantly. Data show that cryopreservation has significant improved survival rates and cumulative pregnancy rates, as well as the safety of ART . Embryo cryopreservation has become a cornerstone in ART. With improved vitrification techniques. Frozen embryos transfer (FET) shows equal or even higher implantation and pregnancy rates than do fresh embryo transfers ART Previous studies show equal or even superior outcomes regarding pregnancy and live birth rates with frozen versus fresh embryo transfer Cryopreserve all embryos have increased substantially in recent years, and according to the recent trend of a freeze-all strategy. This study aims to answer a clinical question encountered in daily practice regarding at what stage embryos should be frozen.

Detailed Description

Cryopreservation of embryos and oocytes has become routine in assisted reproduction technology (ART). Live birth rates following frozen embryo transfers have increased significantly. Data show that cryopreservation has significant improved survival rates and cumulative pregnancy rates, as well as the safety of ART. Embryo cryopreservation has become a cornerstone in ART. With improved vitrification techniques. Frozen embryos transfer (FET) shows equal or even higher implantation and pregnancy rates than do fresh embryo transfers ART .

Previous studies show equal or even superior outcomes regarding pregnancy and live birth rates with frozen versus fresh embryo transfer .

Cryopreservation has several advantages. It maintains supernumerary embryos not used for fresh transfer; allows single-embryo transfer, thus reducing multiple gestations; enables a freeze-all strategy to prevent ovarian hyper stimulation syndrome; is useful for social or medical fertility preservation; and allows embryo biopsy for preimplantation genetic testing, luteal phase stimulation, and dual stimulation protocols .

A recent trend is to perform blastocyst fresh/frozen single-embryo transfers. The advantages include exposing the embryo to a more natural uterine environment. Also, by extending the duration of culture, embryo self-selection will occur and may enable the highest chance of implantation . Due to a potential damage to the expanded blastocyst during vitrification procedure, an emerging clinical question is whether cryopreserving cleavage stage embryos, then thawing and culturing to blastocysts will achieve better outcomes, as compared to transfer of a thawed blastocyst .

The most recent study demonstrated that thawing cleavage embryos, then culturing and transferring them as blastocysts, yields improved pregnancy rates and perinatal outcomes compared to thawed blastocyst embryo transfers . Cryopreserve all embryos have increased substantially in recent years, and according to the recent trend of a freeze-all strategy. This study aims to answer a clinical question encountered in daily practice regarding at what stage embryos should be frozen.

Conditions

Female Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Group 1: (day 5 group)

Women will undergo ICSI, and verification-thawed blastocysts will be transferred after 5 days of ovulation (60cases).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 2: (day 3-5 group)

Women will undergo ICSI, who had cryopreserved embryos on day 3 then thawed and embryos will be allowed for extended cultured for 2 additional days and then will be transferred as blastocysts after 5 days of ovulation (60 cases).

Group Type: EXPERIMENTAL

Extended culture for Group 2: (day 3-5 group)

Intervention Type: OTHER

To investigate thawing day three embryos and culturing them to be transferred as blastocyst that will improve pregnancy rate when compared to transfer thawed frozen blastocyst.

Interventions

Extended culture for Group 2: (day 3-5 group)

To investigate thawing day three embryos and culturing them to be transferred as blastocyst that will improve pregnancy rate when compared to transfer thawed frozen blastocyst.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with history of primary or secondary infertility.

2. Age ≤ 38 years.

3. Female patients having more than 4 vitrified embryos.

4. BMI less than 30 kg/m².

5. Good quality of embryos

Exclusion Criteria

1. Severe male factor infertility.

2. Recurrent implantation failure.

3. Females with uterine Congenital anomalies.

4. Bad quality of embryos.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Sennara

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

International Islamic Center for Population Studies and Researches (IICPSR) - Al-Azhar University

Cairo, Al-Azhar University, Al-Darrasah, Egypt

Countries

Egypt

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

vitrification of embryos

Identifier Type: -

Identifier Source: org_study_id