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Completed

NCT Number: NCT03778866

Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate

The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. However, the oil use and time frame outside the incubators have not been accounted for. This study is to evaluate the use of HEPES buffered medium compared with the bicarbonate-buffered medium on ICSI outcomes.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Qena Fertility Center, Qina, Qena Governorate, Egypt

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ICSI indicated cycles

Exclusion criteria

  • severe medical illness

Treatment and study plan

Bicarbonate-buffered handling medium

Other

The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.

Primary outcomes

  1. live birth rate

    Time frame: 40 weeks

    viable neonate after 30 weeks of Gestation

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 12 weeks

    a positive heartbeat on ultrasound at ≥ 7 weeks of gestation

  2. biochemical pregnancy rate

    Time frame: two weeks

    positive b-hCG at ≥ 14 days following embryo transfer

  3. embryo developmental rates

    Time frame: 6 days of culture

    fertilized oocyte per injected ones and developed embryos per fertilized oocytes

  4. Ongoing pregnancy rate

    Time frame: 16 weeks

    Continued pregnancy after week 12 of gestation

Sponsors and collaborators

Lead sponsor

Muhammad Fawzy

Other Gov

Collaborators

  • Banoon IVF Center
  • Quena IVF Center

Registry information

Official study title

Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Aug 7, 2019

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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