An interventional study of Autologous Platelet-rich Plasma (PRP) Injection in Diminished Ovarian Reserve, Premature Ovarian Insufficiency and Fertility Issues, sponsored by KK Women's and Children's Hospital. Status unknown at 1 site in Singapore. Open to female participants aged 21 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-05-23.
Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Treatment
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.
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.
128 studies on the registry are indexed under Menopause, Premature; 23 are open to participants now.
This study's planned enrollment of 30 is below the median of 47 across 80 interventional studies indexed under Menopause, Premature.
Browse Menopause, Premature studies →KK Women's and Children's Hospital is the lead sponsor of 136 studies on the registry; 33 are open to participants now.
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Exclusion criteria
All 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.
Procedure: Autologous Platelet-rich Plasma (PRP) Injection
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.
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.
Time frame: 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.
Time frame: Baseline, and 4 to 12 weeks after PRP infusion
Clinical pregnancy rates
This is defined as the presence of fetal heartbeat or gestational sac at 6-9 weeks after fresh embryo transfer.
Time frame: Through study completion, an average of 10 months
Live birth rates
Live birth rates before and after 37 weeks of gestation will be one of the secondary outcomes.
Time frame: Through study completion, an average of 10 months
Plan to share: No
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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