Diminished Ovarian ReserveNCT05385848
Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study
A study testing Autologous Platelet-rich Plasma (PRP) Injection in people with Diminished Ovarian Reserve and Premature Ovarian Insufficiency, run by KK Women's and Children's Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve, Premature Ovarian Insufficiency, Fertility Issues
- What is being tested?
- Autologous Platelet-rich Plasma (PRP) Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- May 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Singapore1 site
KK Women's and Children's Hospital
Singapore, 229899
Michelle Loh, 62255554, Michelle.loh.j.m@singhealth.com.sg
Michelle Loh
About this study
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.
Read the 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.
- Being tested
- Autologous Platelet-rich Plasma (PRP) Injection
- Keywords
- Diminished Ovarian Reserve, Premature Ovarian Insufficiency, Poor Ovarian Reserve, Platelet-rich plasma, PRP, In Vitro Fertilisation (IVF), Fertility
- Medical subject headings
- Primary Ovarian Insufficiency, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-rich Plasma (PRP) InjectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PRP Injection Arm | Experimental | 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. Receives: Procedure: Autologous Platelet-rich Plasma (PRP) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, and 4 to 12 weeks after PRP infusion
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.
Measured: Baseline, and 4 to 12 weeks after PRP infusion
Secondary outcomes (2)
Clinical pregnancy rates
This is defined as the presence of fetal heartbeat or gestational sac at 6-9 weeks after fresh embryo transfer.
Measured: Through study completion, an average of 10 months
Live birth rates
Live birth rates before and after 37 weeks of gestation will be one of the secondary outcomes.
Measured: Through study completion, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study startMay 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Loh Jia Min Michelle, KK Women's and Children's Hospital
- Investigators
- Michelle Loh, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385848
- Sponsor's protocol ID
- CIRB 2022/2222
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study
- ClinicalTrials.gov ID
- NCT05385848
- Acronym / sponsor ID
- CIRB 2022/2222
- Keywords
- Diminished Ovarian Reserve, Premature Ovarian Insufficiency, Poor Ovarian Reserve, Platelet-rich plasma, PRP, In Vitro Fertilisation (IVF), Fertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- May 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP Injection Arm | Experimental | Procedure: Autologous Platelet-rich Plasma (PRP) InjectionAll 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. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet-rich Plasma (PRP) InjectionPRP 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. | Procedure or surgery | PRP Injection Arm |
Primary outcome
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.
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.
2 secondary outcomes
Clinical pregnancy rates
Time frame: Through study completion, an average of 10 months
Live birth rates
Time frame: Through study completion, an average of 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
Related trials for Diminished Ovarian Reserve
Not yet recruiting
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
Diminished Ovarian Reserve (DOR)
RecruitingPhase 1
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Infertility, Obesity
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
Not yet recruitingEarly Phase 1
Guishen Yijing Granules for Diminished Ovarian Reserve With Kidney Deficiency Syndrome: A Randomized Controlled Trial
Diminished Ovarian Reserve (DOR)
RecruitingPhase 3
hCG Priming in Women With Diminished Ovarian Reserve
Infertility, Female, Ovarian Reserve
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Loh principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-rich Plasma (PRP) Injection in people with Diminished Ovarian Reserve and Premature Ovarian Insufficiency, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Loh (62255554, michelle.loh.j.m@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ovarian reserves - Anti-Mullerian Hormone (AMH) (time frame: Baseline, and 4 to 12 weeks after PRP infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.