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OpenTrials
Completed

NCT Number: NCT03778736

Using Cumulase for Denudation of Cycles With ≤ 8 Cumulus-oocytes Complexes

The cumulus-corona-oocyte complex (COCs) surrounds each oocyte and must be removed prior to intracytoplasmic sperm injection (ICSI). This is traditionally achieved with a bovine-derived hyaluronidase followed by mechanical denudation through pipetting. A human recombinant hyaluronidase (Cumulase) has been developed to circumvent the problems and concerns associated with the animal origin and lack of purity of the bovine-derived form of the enzyme. whether cumulase offers a higher chance for success after ICSI for women with 8 COCs or lower remains an open question.

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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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ICSI indicated partcipants

Exclusion criteria

  • severe medical disease

Treatment and study plan

Cumulase denudation

Other

Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 16 weeks

    Continued pregnancy after 12 weeks of gestation

Secondary outcomes

  1. Biochemical pregnancy

    Time frame: Two weeks

    Positive b-hCG at two weeks or more after embryo transfer

  2. Clinical pregnancy rate

    Time frame: 7 weeks

    Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation

  3. Embryo developmental rate

    Time frame: 6 days of culture

    fertilized oocytes per injected oocytes and developed embryos per fertilized oocytes

Sponsors and collaborators

Lead sponsor

Ibn Sina Hospital

Other Gov

Collaborators

  • Banoon IVF Center
  • Quena IVF Center

Registry information

Official study title

Can Cumulase Reduce the Shear Stress During Denudation for ICSI Cycles of ≤ 8 Cumulus-oocytes Complexes

Important dates

Study start
2018
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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