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

Primary Purpose

Female Infertility

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Extended culture for Group 2: (day 3-5 group)
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Female Infertility

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1: (day 5 group)

Group 2: (day 3-5 group)

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
May 12, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05858333
Brief Title
Extended Culture of Day 3 to Day 5 Frozen Thawed Day 3 Embryos Versus Day 5 Frozen-Thawed Embryos
Official Title
Pregnancy Outcome of Extended Culture of Day 3 to Day 5 Frozen Thawed Day 3 Embryos Versus Day 5 Frozen-Thawed Embryos
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 17, 2023 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: (day 5 group)
Arm Type
No Intervention
Arm Description
Women will undergo ICSI, and verification-thawed blastocysts will be transferred after 5 days of ovulation (60cases).
Arm Title
Group 2: (day 3-5 group)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Extended culture for Group 2: (day 3-5 group)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To increase the pregnancy rate of cases undergoes to ICSI.
Description
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.
Time Frame
16 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women who will transfer frozen embryos
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
International Islamic Center for Population Studies and Researches (IICPSR) - Al-Azhar University
City
Cairo
State/Province
Al-Azhar University, Al-Darrasah
ZIP/Postal Code
11511
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
31973647
Citation
Boyard J, Reignier A, Chtourou S, Lefebvre T, Barriere P, Freour T. Should artificial shrinkage be performed prior to blastocyst vitrification? A systematic review of the literature and meta-analysis. Hum Fertil (Camb). 2022 Feb;25(1):24-32. doi: 10.1080/14647273.2019.1701205. Epub 2020 Jan 24.
Results Reference
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PubMed Identifier
10856474
Citation
Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. doi: 10.1016/s0015-0282(00)00518-5.
Results Reference
background
PubMed Identifier
27731533
Citation
Martins WP, Nastri CO, Rienzi L, van der Poel SZ, Gracia C, Racowsky C. Blastocyst vs cleavage-stage embryo transfer: systematic review and meta-analysis of reproductive outcomes. Ultrasound Obstet Gynecol. 2017 May;49(5):583-591. doi: 10.1002/uog.17327. Epub 2017 Apr 10.
Results Reference
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PubMed Identifier
32106970
Citation
Nagy ZP, Shapiro D, Chang CC. Vitrification of the human embryo: a more efficient and safer in vitro fertilization treatment. Fertil Steril. 2020 Feb;113(2):241-247. doi: 10.1016/j.fertnstert.2019.12.009.
Results Reference
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PubMed Identifier
26400506
Citation
Ozgur K, Berkkanoglu M, Bulut H, Isikli A, Coetzee K. Higher clinical pregnancy rates from frozen-thawed blastocyst transfers compared to fresh blastocyst transfers: a retrospective matched-cohort study. J Assist Reprod Genet. 2015 Oct;32(10):1483-90. doi: 10.1007/s10815-015-0576-1. Epub 2015 Sep 23.
Results Reference
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PubMed Identifier
34549329
Citation
Rahav-Koren R, Inbar S, Miller N, Wiser A, Yagur Y, Berkowitz C, Farladansky-Gershnabel S, Shulman A, Berkowitz A. Thawing day 3 embryos and culturing to day 5 may be a better method for frozen embryo transfer. J Assist Reprod Genet. 2021 Nov;38(11):2941-2946. doi: 10.1007/s10815-021-02321-y. Epub 2021 Sep 22.
Results Reference
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PubMed Identifier
30388233
Citation
Roque M, Haahr T, Geber S, Esteves SC, Humaidan P. Fresh versus elective frozen embryo transfer in IVF/ICSI cycles: a systematic review and meta-analysis of reproductive outcomes. Hum Reprod Update. 2019 Jan 1;25(1):2-14. doi: 10.1093/humupd/dmy033.
Results Reference
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PubMed Identifier
26364080
Citation
Van Landuyt L, Polyzos NP, De Munck N, Blockeel C, Van de Velde H, Verheyen G. A prospective randomized controlled trial investigating the effect of artificial shrinkage (collapse) on the implantation potential of vitrified blastocysts. Hum Reprod. 2015 Nov;30(11):2509-18. doi: 10.1093/humrep/dev218. Epub 2015 Sep 12.
Results Reference
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PubMed Identifier
28579411
Citation
Wang A, Santistevan A, Hunter Cohn K, Copperman A, Nulsen J, Miller BT, Widra E, Westphal LM, Yurttas Beim P. Freeze-only versus fresh embryo transfer in a multicenter matched cohort study: contribution of progesterone and maternal age to success rates. Fertil Steril. 2017 Aug;108(2):254-261.e4. doi: 10.1016/j.fertnstert.2017.05.007. Epub 2017 Jun 1.
Results Reference
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Extended Culture of Day 3 to Day 5 Frozen Thawed Day 3 Embryos Versus Day 5 Frozen-Thawed Embryos

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