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

NCT03660904 | Completed Phase 2 DMC

• 1 other identifier: Hawaa-3
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Blastocyst Disintegration

Keywords

vitrification; blastocysts; home-made media

Outcome Measures

Primary Outcomes (1)

• blastocyst immediate survival

  The effect of Vitrification protocol on the blastocyst immediate survival

  0 hour at time of thawing

Secondary Outcomes (3)

• pregnancy rate

  2 weeks after transfer

• live birth rate

  9 months

• Blastocyst survival at 6 hours

  6 hours after thawing

Study Arms (2)

Home made media

EXPERIMENTAL

home made vitrification \& thawing kit

Biological: home made vitrification & thawing kit

Commercial media

ACTIVE COMPARATOR

commercially available vitrification \& thawing kit

Biological: commercially made vitrification & thawing kit

Interventions

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

Home made media

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

Commercial media

Eligibility Criteria

• Age: 22 Years - 37 Years
• Gender Eligibility Details: blastocysts of infertile couples
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• extremes of age
• cases of uterine factor
• endometriosis

Sponsors & Collaborators

• Benha University: lead

MeSH Terms

Conditions

Embryo Loss

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: only the investigator knew the procedure and the media provided for each case
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Ob. & Gyn.

Model Details: Group 1 blastocysts were vitrified with the Vit (home made) HM according to shady grove protocol using open system on cryotop vit. device and thawed with gradual thawing technique using HM thawing media according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kit using open system on cryotop vit. device and thawed using Global fast thaw kit. Blastocysts were assessed immediately for survival, 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.

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: September 7, 2018
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: June 15, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09