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

Benha University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Blastocyst Disintegration

Treatments: Biological: commercially made vitrification & thawing kit; Biological: home made vitrification & thawing kit

Study type: Interventional

Funder types: Other

Identifiers

NCT03660904

Hawaa-3

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 74 patients

Sex: Female

Ages: 22 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Home made media

Experimental group

Description:

home made vitrification \& thawing kit

Treatment:

Biological: home made vitrification & thawing kit

Commercial media

Active Comparator group

Description:

commercially available vitrification \& thawing kit

Treatment:

Biological: commercially made vitrification & thawing kit