Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diminished Ovarian Reserve
- Sponsor
- KK Women's and Children's Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in ovarian reserves - Anti-Mullerian Hormone (AMH)
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
Ovarian aging is a principal limiting factor for success in both spontaneous and assisted reproductive techniques (ART) conceptions. This results in diminished ovarian reserve (DOR) and premature ovarian insufficiency (POI), accounting for \~10% of IVF patients in Singapore and worldwide. Existing solutions include nutritional supplementations, high dose gonadotrophin usage, and experimental in-vitro activation with limited effectiveness, while donor oocyte programs or adoption do not provide a genetically related offspring. The substantial clinical burden and lack of effective treatments underscore the highly unmet need in this group of women. Intraovarian autologous platelet-rich plasma (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 mechanism includes 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 POI/DOR a hope in achieving a healthy genetically related offspring. It however, still remains an experimental technique as there are very few small studies published till date, with no locally published data on its use. The investigators propose a pilot study in KK Women's and Children's Hospital IVF (KKIVF) Centre to establish technical expertise, and to evaluate response to PRP to power a randomized controlled trial eventually. Primary outcomes are Anti-Mullerian Hormone (AMH), D2/3 Antral Follicle Count (AFC) and number of oocytes collected at stimulation. The secondary outcome will be clinical pregnancy and live birth rates. Thirty women with DOR/POI will be recruited over a 1 year period. The investigators hypothesize that PRP increases the overall pregnancy and live birth rates in these women.
Investigators
Loh Jia Min Michelle
Principal Investigator
KK Women's and Children's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in ovarian reserves - Anti-Mullerian Hormone (AMH)
Time Frame: Baseline, and 4 to 12 weeks after PRP infusion
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.
Change in ovarian reserves - Antral Follicular Count (AFC)
Time Frame: Baseline, and 4 to 12 weeks after PRP infusion
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.
Secondary Outcomes
- Clinical pregnancy rates(Through study completion, an average of 10 months)
- Live birth rates(Through study completion, an average of 10 months)