Ovarian rejuvenation for menopausal or perimenopausal women using autologous platelet rich plasma (A-PRP) injection into the ovaries, for women seeking in vitro fertilisation (IVF) treatment, aiming to improve IVF outcomes.
Ovarian rejuvenation using intra-ovarian injection of autologous platelet-rich plasma (A-PRP) for peri-menopausal and menopausal women.
Fertility North
400 participants
Nov 1, 2019
Interventional
Conditions
Summary
It is anticipated that ovarian rejuvenation using autologous platelet-rich plasma (A-PRP) injected into the ovaries will improve IVF outcomes in subsequent IVF cycles using mild ovarian stimulation for perimenopausal and menopausal women. In the non-randomised prospective trial, around 30mLs of your own blood (autologous) will be collected to produce around 4-5mLs of A-PRP. Around 2-2.5mLs of A-PRP will be injected into each ovary using transvaginal ultrasound guidance or laparoscopy, either at the same time as a transvaginal egg collection, or at a separate event. Follicle, egg and embryo numbers, pregnancy rates, and hormones levels (anti-mullerian hormone (AHM) and follicle stimulating hormone (FSH)) will be compared pre and post the injection of A-PRP.
Eligibility
Inclusion Criteria5
- i. Low AMH (<1.5 pmol/L).
- ii. High basal FSH (>14 mIU/mL).
- iii. Classified with premature ovarian failure (POF) (Menopausal reproductive hormones <40 years of age).
- iv. Classified as having poor ovarian response (POR) (As per Bologna Criteria).
- v. A history of poor IVF outcomes, including failed oocyte retrievals, no mature oocytes available for insemination, failed fertilisation of oocytes, no embryos available for transfer.
Exclusion Criteria4
- i. Patients with normal hormonal profiles, previous acceptable / good responses to ovarian stimulation and good numbers of embryos available for embryo transfer or cryopreservation (greater than 3).
- ii. Patients with POF due to a genetic condition e.g. Turners syndrome.
- iii. Patients with Idiopathic thrombocytopenia (autoimmune platelet deficiency).
- iv. Patients who are unable to undergo an IVF treatment cycle for any reason.
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Interventions
Autologous platelet-rich plasma (A-PRP) will be injected into the ovaries of perimenopausal and menopausal women. The PRP preparation kit is Alocuro PRO PRP 30mL device approved by the Therapeutics Goods Agency (TGA) listed on the Australian Register of Therapeutic Goods (ARTG) as a class II medical device, manufacturer - GoodmorningBio Co Ltd, Republic of Korea. The kit contains:*Venepuncture equipment; Butterfly needle / White top syringe / Yellow top syringe x 4 (each containing 1mL of anti-coagulant). *PRP Preparation equipment; 30mL PRO PRP device (centrifuging tube) / S-Monovette-needle. Trained phlebotomist's will draw 30mLs of blood as per the manufacturer's instructions. A scientist trained in the preparation of A-PRP will prepare the blood sample as per the manufacturer's instructions, 30mLs of blood will harvest around 4-5mLs of A-PRP. A FRANZCOG trained fertility specialist will inject the A-PRP into both ovaries via transvaginal ultrasound guidance or laparoscopy, using an oocyte pick-up (OPU) needle. If one ovary cannot be safely accessed, only one will be injected, around 2-2.5mLs of A-PRP will be injected per ovary. The injection will occur under either local anaesthetic (LA) or general anaesthetic (GA), either within a cycle of mild ovarian stimulation IVF at the time of the transvaginal oocyte aspiration (TVOA), or outside of a cycle of IVF in the follicular phase of menstruation, or for patients with amenorrhoea at any point. The intraovarian injection (IOI) of A-PRP may be repeated on subsequent IVF cycles. The blood collection and A-PRP preparation will take place in an RTAC / RTC / NATA accredited fertility clinic – Fertility North. The intraovarian injection will take place in a treatment room at Fertility North (if performed under LA) or Joondalup Health Campus hospital theatres (if performed under GA).
Locations(1)
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ACTRN12619001206112