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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pregnancy Outcome of Extended Culture of Day 3 to Day 5 Frozen Thawed Day 3 Embryos Versus Day 5 Frozen-Thawed Embryos

Conditions
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Female Infertility

Intervention / Treatment
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* Other: Extended culture for Group 2: (day 3-5 group)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with history of primary or secondary infertility. Age ≤ 38 years. Female patients having more than 4 vitrified embryos. BMI less than 30 kg/m². Good quality of embryos Exclusion Criteria: Severe male factor infertility. Recurrent implantation failure. Females with uterine Congenital anomalies. Bad quality of embryos.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1: (day 5 group)<br>Women will undergo ICSI, and verification-thawed blastocysts will be transferred after 5 days of ovulation (60cases). | |
| Experimental: Group 2: (day 3-5 group)<br>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). | Other: Extended culture for Group 2: (day 3-5 group)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To increase the pregnancy rate of cases undergoes to ICSI. | Pregnancy rates will be determined in each of the two groups and compared to each other in three stages in clinical pregnancy, ongoing pregnancy and live pregnancy rates. | 16 months |