NCT05858333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

May 4, 2023

Last Update Submit

June 12, 2024

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group 1: (day 5 group)

NO INTERVENTION

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

Group 2: (day 3-5 group)

EXPERIMENTAL

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)

Interventions

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

Group 2: (day 3-5 group)

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who will transfer frozen embryos
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Severe male factor infertility.
  • Recurrent implantation failure.
  • Females with uterine Congenital anomalies.
  • Bad quality of embryos.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Al-Azhar University, Al-Darrasah, 11511, Egypt

Location

Related 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.

    PMID: 31973647BACKGROUND

  • 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.

    PMID: 10856474BACKGROUND

  • 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.

    PMID: 27731533BACKGROUND

  • 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.

    PMID: 32106970BACKGROUND

  • 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.

    PMID: 26400506BACKGROUND

  • 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.

    PMID: 34549329BACKGROUND

  • 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.

    PMID: 30388233BACKGROUND

  • 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.

    PMID: 26364080BACKGROUND

  • 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.

    PMID: 28579411BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 15, 2023

Study Start

April 1, 2022

Primary Completion

September 17, 2023

Study Completion

December 1, 2023

Last Updated

June 14, 2024

Record last verified: 2024-06

Locations

EG(1)