Effect of Timing of Oocyte Denudation Before ICSI in an Oocyte Donation Model

Not Applicable

Completed

• Conditions: Fertility
• Interventions: Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injection

• Registration Number: NCT03121924
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte donation model.

Detailed Description

There is an intense communication inside the follicular structure. Bidirectional information between the oocyte and the granulosa cells is needed for a normal follicular development and oocyte competence.

There are conflicting results on the effect of pre-incubation time in ICSI.

It is not clear the proper time to denudate the oocyte from the somatic cells prior to ICSI, and some authors describe a negative impact of the premature cummulus removal on the ICSI results.

The aim of this study is to investigate wheter a preincubation time between oocyte retireval and injection has any effect on the ICSI ( intracytoplasmatic sperm injection) results .

Study Timeline

• Study Start: 2015-12-01
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Primary Completion: 2018-12-01
• Status Verified: 2019-08
• Study Completion: 2019-08-01
• Last Update Submitted: 2020-11-27
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 375

Inclusion Criteria

• Oocytes retrieved from healthy donors, younger than 32 years old , with proven maternity(preference), who meet the admission criteria of ovodonation program:
• The oocytes included will be the product of antagonist stimulation protocol and with Gnrh agonists trigger. (see annex)
• Healthy women under 50 years of age , who meet the criteria as receptors into the ovodonation program.
• Oocytes retrieved after 36.5 h + -1 h of administration of triptorelin acetate.
• Only mature oocytes, in stage MII, will be included and injected.
• Use of fresh or thawed semen for the ICSI.

Exclusion Criteria

• Cases of severe male factor such as azoospermia or severe oligo-astheno-teratospermia( alone or combinated)
• Sperm samples from surgical procedures (biopsy / testicular or epididymal puncture)
• Donors with a polycystic ovarian profile, according to The Androgen Excess and PCOS Society (AES), 2006.
• Thawed donated oocytes
• Oocytes from patients who have previously donated within a period of less than three months.
• Donors whith poor response (oocyte retrieved less than < 4 oocytes).
• Suspicion or signs of Endometriosis in donor patient.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed oocyte denudation	timing for oocyte denudation and Intracytoplasmatic Sperm injection	After the retrieval , sybling oocytes were assigned to one o more recipient and then ,the oocytes were randomized in two arms . In this arm, the oocyte are denuded and injected after 4 hours from the pick up .
Immediately oocyte denudation	timing for oocyte denudation and Intracytoplasmatic Sperm injection	After the retrieval , sybling oocytes were assigned to one o more recipient and then ,the oocytes were randomized in two arms . The first arm is the immediately denudation and immediately ICSI of the oocytes, and in the second arm the oocyte are denuded and injected after 4 hours from the pick up .

Primary Outcome Measures

Name	Time	Method
Number of M2 oocytes at injection	four hours after oocyte retrieval	Asessment of the number of M2 oocytes was made after the oocyte denudation and ICSI
Number of normal fertilized oocytes after ICSI	24 hours	Asessment of the normal fertilization rate was made 24 hours after the intervention.
Number of cleaving embryos	72 hours	The embryo cleavage was evaluated after 48 hours and 72 hours after the ICSI was performed.
Number of TOP embryos	72 hours	The embryos were morfologically classified into 4 categories . It considered TOP embryos those correctly fertilized at day 1, and with regular 6 to 8 cells at day 2 with less than 20% fragmentation and without multinuclear blastomeres.

Secondary Outcome Measures

Name	Time	Method
Implantation rate	14 days after embryo trasfer	The implantation rate was the ratio between the number of gestacional sacs and the number of transferred embryos.
Clinical pregnancy rate	6 to 7 week	Clinical pregnancy is confirmed by ultrasonography ,when one or more gestational sacs with heart activity are seen.

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Ciudad de buenos Aires, Buenos Aires, Argentina