RecruitingACTRN12619001206112

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.


Sponsor

Fertility North

Enrollment

400 participants

Start Date

Nov 1, 2019

Study Type

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

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is investigating a technique called ovarian rejuvenation using platelet-rich plasma (PRP) — a substance made from your own blood — to try to improve IVF outcomes in women who are menopausal or approaching menopause. As women age, the number and quality of eggs they produce naturally declines, and for many women seeking IVF, this becomes a significant barrier. Standard IVF often yields little or no result for women in this situation. In this study, a small amount of your own blood (about 30 mL) is processed to create a concentrated PRP solution, which is then injected directly into the ovaries using ultrasound guidance. The hope is that growth factors in the PRP can stimulate the ovaries to become more responsive, potentially producing more follicles and eggs. The study will measure hormone levels, number of eggs retrieved, and pregnancy rates before and after the procedure. You may be eligible if you are a woman aged 18 to 45 seeking IVF treatment and have been found to have poor ovarian function — such as low AMH levels, high FSH levels, or a history of poor or failed IVF cycles. Women with premature ovarian failure due to genetic conditions like Turner syndrome are not eligible. This is a hopeful option for women who have experienced repeated IVF setbacks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Therapeuti

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)

Joondalup Health Campus - Joondalup

WA, Australia

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ACTRN12619001206112


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