Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study

IVF Clinical Trial

Official title:

Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05385848
• Other study ID #: CIRB 2022/2222
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: March 2024

Study information

• Verified date: May 2022
• Source: KK Women's and Children's Hospital
• Contact: Michelle Loh
• Phone: 62255554
• Email: michelle.loh.j.m[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diminished Ovarian Reserve
• Fertility Issues
• Infertility
• IVF
• Menopause, Premature
• Premature Ovarian Insufficiency
• Primary Ovarian Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, and 4 to 12 weeks after PRP infusion
Primary	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.	Baseline, and 4 to 12 weeks after PRP infusion
Secondary	Clinical pregnancy rates	This is defined as the presence of fetal heartbeat or gestational sac at 6-9 weeks after fresh embryo transfer.	Through study completion, an average of 10 months
Secondary	Live birth rates	Live birth rates before and after 37 weeks of gestation will be one of the secondary outcomes.	Through study completion, an average of 10 months