Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
In Vitro Maturation of Oocytes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: prospective randomized control trialMasking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 36 years
Gender
Only males

Description

The current IVM system in use in the clinic has a single step approach and seems to be less efficient compared to research and literature findings using a biphasic CAPA-IVM system in terms of maturation. To ascertain the efficiency of the biphasic CAPA-IVM system, both standard IVM and CAPA-IVM will...

The current IVM system in use in the clinic has a single step approach and seems to be less efficient compared to research and literature findings using a biphasic CAPA-IVM system in terms of maturation. To ascertain the efficiency of the biphasic CAPA-IVM system, both standard IVM and CAPA-IVM will be performed on sibling oocytes: maturation in standard IVM in the investigator's center is on average 47.5%, where CAPA-IVM reaches 62% maturation in literature. The investigators aim to prove superiority of the CAPA-IVM system in terms of maturation. Also fertilization and embryo development will be compared. The participants admitted to the study will be receiving both the standard IVM treatment for part of the participant's oocytes and the biphasic CAPA IVM system for the second part of the participant's oocytes. In one ovary a regular oocyte pick up (OPU) will take place with oocytes assigned to the standard IVM treatment, in the other ovary the CAPA IVM system will be applied. This means oocytes that are liberated from the follicular environment need to be exposed immediately to the inhibiting CNP peptide and herefore the tubes to collect the follicle fluid from the punctured follicles are prefilled with CNP supplemented medium. The OPU procedure is identical for both ovaries and according to our standard OPU IVM procedure with the sole difference of empty or prefilled tubes to collect follicle fluid. Oocytes from the 2 ovaries are separately processed in the lab according to attributed protocol. After IVM of oocytes, mature oocytes are subjected to ICSI with partner's sperm or donor sperm. Partner's sperm sample will be frozen at the latest the day of egg retrieval and will be thawed the day of intracytoplasmic sperm injection (ICSI): due to the use of 2 different IVM protocols with 2 different time lines (30 hours maturation versus 24 hours+30 hours maturation), ICSI will take place on two consecutive days with a freshly thawed straw of sperm cells for each day. Embryo development is followed until day 3 (cleavage stage) after ICSI. All embryos of sufficient quality will be vitrified for a deferred embryo transfer in a hormone replacement therapy (HRT) cycle. One embryo will be selected for embryo transfer based on the morphological quality assessment parameters, with the better quality as first choice for transfer, regardless the preceding IVM method. Frozen single embryo transfer cycles are repeated until pregnancy.

Tracking Information

NCT #
NCT04285892
Collaborators
Not Provided
Investigators
Principal Investigator: Michel De Vos, MD, PhD VUB- UZ Brussel