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PICSI RCT in Couples With a Previous Poor Fertilisation Cycle in IVF

Primary Purpose

Infertility, IVF

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
ICSI
PICSI
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring PICSI

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Couples with <50% fertilisation in their first ICSI cycle, and scheduled for their second ICSI/PICSI cycle

Exclusion Criteria:

  • Women with diminished ovarian reserves (AMH <1.2ng/ml) or severe endometriosis (rAFS Stage III or IV)
  • Male partner with severe oligoasthenoteratozoospermia (Density < 5 million, Total motility < 40) or those require surgically retrieved sperm
  • Couples using donor gametes
  • Couples using frozen gametes
  • Couples undergoing split IVF-ICSI cycles
  • Couples where a freeze all approach has been done, either clinically indicated or secondary to patient choice

Sites / Locations

  • KK Women's and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ICSI

PICSI

Arm Description

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
The presence of fetal heartbeat or gestational sac at 6-9 weeks after fresh embryo transfer
Miscarriage rate
Pregnancy loss before 23+6 completed weeks after confirmation of clinical pregnancy

Secondary Outcome Measures

Fertilisation rate
Successful embryo transfer
Live birth rate
Live birth after 24 completed weeks of gestation

Full Information

First Posted
August 17, 2021
Last Updated
October 3, 2023
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05017740
Brief Title
PICSI RCT in Couples With a Previous Poor Fertilisation Cycle in IVF
Official Title
A Randomised Clinical Trial in the Use of Physiological Intra-cytoplasmic Spermatozoa Injection (PICSI) in Couples With a Previous Poor Fertilisation Cycle in In-vitro Fertilisation.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Poor fertilisation plays a significant role in poor artificial reproductive technique outcomes. Male factor infertility accounts for a large portion of such cases. Several modalities have been proposed as a solution, including physiological intra-cytoplasmic sperm injection (PICSI). PICSI is a technique used to select the sperm to use in intra-cytoplasmic sperm injection (ICSI) treatment. It involves placing sperm with hyaluronic acid, a natural compound found in the body. PICSI identifies sperm that can bind to hyaluronic acid and these sperms are selected for use in treatment. Some studies have suggested that PISCI may be advantageous to reduce miscarriage. However, the evidence is not strong and it remains unknown if PICSI is effective in a selected group of couples with a history of poor fertilisation. Based on previous medical records, we observed a higher clinical pregnancy rate (CPR) and a trend towards lower miscarriage rates with PICSI. To verify the findings and address the clinical gap, we propose a randomised controlled trial (RCT) with 234 couples (117 in each group) to evaluate the effectiveness of PICSI comparing with ICSI for improving CPR and reducing miscarriage rate in couples with a fertilisation rate of <50% in their first cycle of ICSI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, IVF
Keywords
PICSI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomised to undergo PICSI or standard ICSI in a 1:1 treatment ratio.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Trial participants, research team collecting data outcome, and all study team members except the embryologists will be blinded to treatment allocation. It is not possible to conceal allocation to the embryologists, who will perform the intervention.
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICSI
Arm Type
Active Comparator
Arm Title
PICSI
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
ICSI
Intervention Description
In ICSI, the sperm is chosen based on motility and gross morphology to be inseminated directly into the cytoplasm of the oocyte.
Intervention Type
Procedure
Intervention Name(s)
PICSI
Intervention Description
In PICSI, the sperm is selected via hyaluronic binding before insemination into the cytoplasm of the oocyte.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
The presence of fetal heartbeat or gestational sac at 6-9 weeks after fresh embryo transfer
Time Frame
6-9 weeks after fresh embryo transfer
Title
Miscarriage rate
Description
Pregnancy loss before 23+6 completed weeks after confirmation of clinical pregnancy
Time Frame
6 to 23+6 gestational weeks
Secondary Outcome Measure Information:
Title
Fertilisation rate
Description
Successful embryo transfer
Time Frame
2-5 days after oocyte retrieval
Title
Live birth rate
Description
Live birth after 24 completed weeks of gestation
Time Frame
After 24 completed weeks of gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Couples with <50% fertilisation in their first ICSI cycle, and scheduled for their second ICSI/PICSI cycle Exclusion Criteria: Women with diminished ovarian reserves (AMH <1.2ng/ml) or severe endometriosis (rAFS Stage III or IV) Male partner with severe oligoasthenoteratozoospermia (Density < 5 million, Total motility < 40) or those require surgically retrieved sperm Couples using donor gametes Couples using frozen gametes Couples undergoing split IVF-ICSI cycles Couples where a freeze all approach has been done, either clinically indicated or secondary to patient choice
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Wen Ng, MPH
Phone
+65 63948113
Email
ng.xiang.wen@kkh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu Qi Tan, MBBS
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Wen Ng, MPH
Phone
+65-63948113
Email
Ng.Xiang.Wen@kkh.com.sg
First Name & Middle Initial & Last Name & Degree
Shu Qi Tan, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PICSI RCT in Couples With a Previous Poor Fertilisation Cycle in IVF

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