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Completed

NCT Number: NCT03660904

A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst

This study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).

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Key information

Conditions

Blastocyst Disintegration Abortion, Spontaneous Death Embryo Loss Female Urogenital Diseases and Pregnancy Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

22 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

Group 1 blastocysts were vitrified with the Vit HM according to shady grove protocol using open system on cryotopvit. device and thawed with gradual thawing technique using HM according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kitusing open system on cryotopvit. device and thawed using Gobal fast thaw kit. Blastocysts were subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age of the patients 22-37
  • All vitrified & thawed blastocyst.
  • unexplained cases or ovarian factors for infertility.

Exclusion criteria

  • extremes of age
  • cases of uterine factor
  • endometriosis

Treatment and study plan

home made vitrification & thawing kit

Biological

home made vitrification was made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too

commercially made vitrification & thawing kit

Biological

commercially available vitrification & thawing kit were made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too

Primary outcomes

  1. blastocyst immediate survival

    Time frame: 0 hour at time of thawing

    The effect of Vitrification protocol on the blastocyst immediate survival

Secondary outcomes

  1. pregnancy rate

    Time frame: 2 weeks after transfer

    clinical pregnancy rate in these cases

  2. live birth rate

    Time frame: 9 months

    live birth rate of positive pregnancy cases

  3. Blastocyst survival at 6 hours

    Time frame: 6 hours after thawing

    The effect of Vitrification protocol on the blastocyst survival after 6 hours

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst Survival, Expansion and Implantation

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 7, 2018
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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