NCT02420171

Brief Summary

Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In Vitro culture and detect the the effect upon embryo quality and implantation potential.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

2 active sites

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

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

April 14, 2015

Last Update Submit

July 11, 2016

Conditions

Infertility

Keywords

In Vitroembryo qualityIntracytoplasmic sperm injection

Outcome Measures

Primary Outcomes (1)

  • clinical Pregnancy rate ( % )

    6 months

Secondary Outcomes (2)

  • Blastocyst rate ( % )

    6 months

  • Blastocyst quality rate ( % )

    6 months

Study Arms (2)

In Vitro culture media with insulin

ACTIVE COMPARATOR

We will add insulin to the single step culture media to monitor the embryogenesis

Other: Adding insulin to In Vitro culture media

In Vitro culture media without insulin m

NO INTERVENTION

The embryos will be cultured in the media without insulin and compare this arm as the control arm with the interventional one.

Interventions

Adding insulin to In Vitro culture mediaOTHER

We will add insulin for in vitro culture of human embryos

In Vitro culture media with insulin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal responder
  • PCOS
  • Tubal factor infertility
  • mild asthenozoospermia

You may not qualify if:

  • patient over 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Banon IVF Center

Asyut, Egypt

Location

Ibnsina IVF center

Sohag, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Laboratory Director

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 17, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 13, 2016

Record last verified: 2016-07

Locations

EG(2)