CClinicalTrials.gg
CompletedNCT02418416CISCUpdated Sep 27, 2018

Novel Approach With Double Agent Artificial Oocyte Activation for Repeated Fertilization Failure Due to Combined Sperm and Oocyte Factor

An interventional study of Oocyte double chemical activation in Infertility, sponsored by Ibn Sina Hospital. Completed at 3 sites in 2 countries. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-27.

Sponsored by Ibn Sina Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 44 Years
Sex
Female
01

Study summary

Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection.

Read the detailed description

In some cases undergoes assisted reproduction technique specially Intracytoplasmic sperm injection, in subgroup of patient they fail to fertilize or poorly fertilized, some authors recommend chemical activation for those group of patient with Ca ionophore but still with Ca ionophore there are some cases with total fertilization failure or low fertilization specially in those patient with 2 separate factors like teratozoospermia with poor quality Oocytes so the investigators decided to test the effect of double activation methods by using tow agents proven with life birth rate Ca ionophore and strontium chloride.

We Do intracytoplasmic sperm injection and immediately activate oocyte with Ca Ionophore followed by strontium chloride activation and monitoring the embryogenesis until the blastocyst formation and pregnancy outcome in multicenter assessment.

02

Conditions studied

  • Infertility

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03

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • poor sperm
  • poor quality Oocytes
  • previous failed fertilization
  • previous poor embryogenesis

Exclusion criteria

Exclusion Criteria:

  • normal patient
  • previous successful outcome
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    Double activation

    The Oocytes in this arm will undergo double activation with Ca ionophore 5 micro mol for 20 min them Strontium chloride 10 micro mol for 60 min.

    Other: Oocyte double chemical activation

  • No intervention
    Control arm

    The Oocytes will undergo Intracytoplasmic sperm injection only

Interventions

  • OtherOocyte double chemical activation

    Oocyte double chemical activation

05

What researchers measure

Primary outcomes

  1. Clinical Pregnancy rate ( % )

    To predict percentage of pregnant women from those will undergo Embryo transfer

    Time frame: 3 months

Secondary outcomes

  1. Blastocyst rate ( % )

    Number of embryos will reach blastocyst stage at day 5 post Intracytoplasmic sperm injection

    Time frame: 3 months

06

Study locations

3 sites
  • Al Barka fertility center
    Bahrain, Bahrain
  • Banon fertility center
    Assiut, Egypt
  • IbnSina IVF unit, IbnSina Hospital, El Areef Square
    Sohag, 12345, Egypt
07

Registry details

Key details

Study ID
NCT02418416
Lead sponsor
Ibn Sina Hospital
Collaborators
Al Baraka Fertility Hospital, Banon IVF Center Assiut, Egypt
Responsible party
Muhammad Fawzy (IVF Laboratory Director, Ibn Sina Hospital) — Principal investigator
First posted
Apr 16, 2015
Start date
May 6, 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Sep 27, 2018

Oversight

Data monitoring committee
No
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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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