Infertility
Conditions
Brief summary
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.
Interventions
OTHERCumulase denudation
Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve
Sponsors
Banoon IVF Center
Quena IVF Center
Ibn Sina Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* ICSI indicated partcipants
Exclusion criteria
* severe medical disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 16 weeks | Continued pregnancy after 12 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy | Two weeks | Positive b-hCG at two weeks or more after embryo transfer |
| Clinical pregnancy rate | 7 weeks | Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation |
| Embryo developmental rate | 6 days of culture | fertilized oocytes per injected oocytes and developed embryos per fertilized oocytes |
Countries
Egypt
Outcome results
None listed