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

Female Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05858333
• Other study ID #: vitrification of embryos
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2024
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 1, 2023
• Est. primary completion date: September 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Egypt	International Islamic Center for Population Studies and Researches (IICPSR) - Al-Azhar University	Cairo	Al-Azhar University, Al-Darrasah

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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