Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study
1 other identifier
interventional
30
1 country
1
Brief Summary
The investigators propose a pilot study to determine if autologous platelet-rich plasma (PRP) improves ovarian reserves and In-vitro fertilisation (IVF) outcomes in women with diminished ovarian reserve / premature ovarian insufficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 4, 2022
CompletedFirst Posted
Study publicly available on registry
May 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedMay 23, 2022
May 1, 2022
1.8 years
May 4, 2022
May 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in ovarian reserves - Anti-Mullerian Hormone (AMH)
Markers of ovarian reserve will be measured - Anti-Mullerian Hormone (AMH) levels on Day 2-3 of menses. Changes in ovarian reserve will be measured before and after the PRP infusion.
Baseline, and 4 to 12 weeks after PRP infusion
Change in ovarian reserves - Antral Follicular Count (AFC)
Markers of ovarian reserve will be measured - Antral Follicular Count (AFC) on Day 2-3 of menses. Changes in ovarian reserve will be measured before and after the PRP infusion.
Baseline, and 4 to 12 weeks after PRP infusion
Secondary Outcomes (2)
Clinical pregnancy rates
Through study completion, an average of 10 months
Live birth rates
Through study completion, an average of 10 months
Study Arms (1)
PRP Injection Arm
EXPERIMENTALAll patients recruited will come down to KKIVF Centre on Day 2-3 of the menstrual cycle to do blood tests (Anti-Mullerian Hormone (AMH)) and an ultrasound scan (Antral Follicular Count (AFC)). In the same menstrual cycle/month, autologous PRP injection will be done on Day 5-15 of the cycle. Patients will return to KKIVF Centre 1-3 months after the PRP injection on Day 2-3 of the menstrual cycle to repeat blood tests (AMH) and Ultrasound scan (AFC). IVF stimulation cycle as per KKIVF protocol will be started within 6 months from PRP injection. Patients will be followed up as per routine, with no more additional visits pertaining specifically to the study.
Interventions
PRP contains a high concentration of platelets which contains multiple vaso-active peptides and cytokines such as Vascular Endothelial Growth Factor (VEGF), Platelet-Derived Growth Factor (PDGF) and Sphingosine-1-phosphate. Many of these cytokines have been implicated in important roles in ovarian function, follicular genesis and oocyte maturation. Intraovarian autologous PRP infusion was recently introduced in the context of addressing ovarian insufficiency, with several studies showing an increase in ovarian function and promising ART outcomes. Possible mechanisms include anti-inflammatory and mitogenic potentials in this growth factor rich fraction contributing towards tissues regeneration. Through being involved in the cell regeneration cycle, autologous PRP potentially gives women with premature ovarian insufficiency (POI) or diminished ovarian insufficiency (DOR) hope in achieving a healthy genetically related offspring.
Eligibility Criteria
You may qualify if:
- Diminished ovarian reserves AND/OR;
- Anti-Mullerian Hormone (AMH) 0.2-0.5ng/ml or
- At least 2 Follicle Stimulating Hormone (FSH) readings of \>25 (mIU/L) or
- AFC \< 5
- Poor Ovarian Response of \<4 oocytes retrieved at a prior IVF stimulation cycle with gonadotrophin doses of 450u per day
You may not qualify if:
- Amenorrhea of \> 1 years
- Medical conditions - Diabetes Mellitus, Hypertension, Collagen vascular diseases, Thyroid disease
- Patients presenting with anemia and thrombophilic disorders
- Inability to be monitored for at least 1 year at the treating centre
- Lack of suitable sperm for Intracytoplasmic Sperm Injection (ICSI) (eg. Azoospermia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KK Women's and Children's Hospital
Singapore, 229899, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Loh
KK Women's and Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 4, 2022
First Posted
May 23, 2022
Study Start
May 1, 2022
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
May 23, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share