Clinical trial NCT05385848: Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study
Official title: Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diminished Ovarian Reserve
Premature Ovarian Insufficiency
Fertility Issues
IVF
Keywords: Diminished Ovarian Reserve
Premature Ovarian Insufficiency
Poor Ovarian Reserve
Platelet-rich plasma
PRP
In Vitro Fertilisation (IVF)
Fertility
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2022-05-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria

* 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
* AFC \< 5
* Poor Ovarian Response of \<4 oocytes retrieved at a prior IVF stimulation cycle with gonadotrophin doses of 450u per day

Exclusion criteria

* 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)

Primary outcomes:
measure: Change in ovarian reserves - Anti-Mullerian Hormone (AMH)
timeFrame: Baseline, and 4 to 12 weeks after PRP infusion
measure: Change in ovarian reserves - Antral Follicular Count (AFC)
timeFrame: Baseline, and 4 to 12 weeks after PRP infusion
Secondary outcomes:
measure: Clinical pregnancy rates
timeFrame: Through study completion, an average of 10 months
measure: Live birth rates
timeFrame: Through study completion, an average of 10 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Michelle Loh
role: PRINCIPAL_INVESTIGATOR
References: