Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in ovarian reserves - Anti-Mullerian Hormone (AMH)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Poor Ovarian Response of <4 oocytes retrieved at a prior IVF stimulation cycle with gonadotrophin doses of 450u per day
排除标准
- •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)
结局指标
主要结局
Change in ovarian reserves - Anti-Mullerian Hormone (AMH)
时间窗: 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)
时间窗: 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.
次要结局
- Clinical pregnancy rates(Through study completion, an average of 10 months)
- Live birth rates(Through study completion, an average of 10 months)
研究者
Loh Jia Min Michelle
Principal Investigator
KK Women's and Children's Hospital