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

May 17, 2022 updated by: Loh Jia Min Michelle, KK Women's and Children's Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP Injection Arm

All patients recruited will come down to KKIVF Centre on Day 2-3 of the menstrual cycle to do blood tests (Anti-Mullerian Hormone (AMH)) and an ultrasound scan (Antral Follicular Count (AFC)). In the same menstrual cycle/month, autologous PRP injection will be done on Day 5-15 of the cycle.

Patients will return to KKIVF Centre 1-3 months after the PRP injection on Day 2-3 of the menstrual cycle to repeat blood tests (AMH) and Ultrasound scan (AFC).

IVF stimulation cycle as per KKIVF protocol will be started within 6 months from PRP injection. Patients will be followed up as per routine, with no more additional visits pertaining specifically to the study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ovarian reserves - Anti-Mullerian Hormone (AMH)
Time Frame: 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.
Baseline, and 4 to 12 weeks after PRP infusion
Change in ovarian reserves - Antral Follicular Count (AFC)
Time Frame: 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.
Baseline, and 4 to 12 weeks after PRP infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rates
Time Frame: Through study completion, an average of 10 months
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
Live birth rates
Time Frame: Through study completion, an average of 10 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Michelle Loh, KK Women's and Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB 2022/2222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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