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Clinical Trials/NCT07579858
NCT07579858CompletedPhase 3

Efficacy of Platelet-rich Plasma on Blastocyst Formation in ICSI Cycles Involving Low-quality Sperm: A Randomised Study

Stella Maris Women and Children Hospital1 site in 1 country66 target enrollmentStarted: January 1, 2023Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
66
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The goal of this clinical trial is to learn if platelet rich plasma (PRP) works to improve embryo development rates and embryo quality in IVF cycles, involving male adult patients with severe sperm disorders.

The main questions it aims to answer are:

  • Does PRP improve sperm quality of male adult patients undergoing IVF?
  • Does PRP improve embryo development and embryo quality of the IVF patients?

Researchers will compare embryos from IVF patients treated with PRP to those not treated with PRP to see if PRP improves embryo development and embryo quality.

Participants will:

  • Provide semen sample for IVF
  • Provide blood sample for PRP preparation
  • Have PRP obtained from their blood added to their sperm sample

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
28 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •sperm concentration of less than five million/mL;
  • •total sperm motility < 42%;
  • •sperm normal morphology of less than four percent;
  • •provided informed consent to participate in the study

Exclusion Criteria

  • •leukospermia;
  • •a history of HIV, hepatitis, or other reproductive tract infections;
  • •a history of utilising drugs or therapies within the past three months, such as antibiotics, radiotherapy, chemotherapy, psychiatric medications, or anabolic steroids;
  • •a history of fever within the past three months;
  • •a history of testicular carcinoma;
  • •using a second ejaculate sample for ICSI;
  • •using a cryopreserved semen sample for ICSI;
  • •a history of retrograde ejaculation;
  • •a history of coagulopathy

Investigators

Sponsor
Stella Maris Women and Children Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Binarwan Halim

Associate Professor

Stella Maris Women and Children Hospital

Study Sites (1)

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