Premature Ovarian InsufficiencyNCT06645379
Application of Platelet-rich Plasma (PRP) in Reproductive Medicine
A study testing Platelet-Rich Plasma (PRP) Injections in people with Premature Ovarian Insufficiency and Intrauterine Adhesion, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
Female fertility is affected by many factors, such as ovarian function, fallopian tube patency, uterine environment, and mental state, among which the ovaries and endometrium are more important. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency, Intrauterine Adhesion, Poor Ovarian Response
- What is being tested?
- Platelet-Rich Plasma (PRP) Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2024to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premature ovarian insufficiency: ① Women aged >18 and <40 years old; ② Oligomenorrhea or amenorrhea for more than 4 months (excluding pregnancy); ③ Basal follicle stimulating hormone (FSH) >25IU/L (interval >4 weeks) at least 2 times, or total antral follicles (AFC) <5, or anti-Mullerian hormone (AMH) <1.1ng/mL.
- Poor ovarian response: ① Advanced age (≥40 years) or other risk factors for poor ovarian response; ② Poor ovarian response in previous IVF cycle, with ≤3 oocytes retrieved using conventional protocols; ③ Decreased ovarian reserve (antral follicle count <5~7 or anti-Müllerian hormone <0.5~1.1 ug/L). Meeting any 2 of the above 3 criteria is sufficient.
- Intrauterine adhesion: ① Diagnosed by hysteroscopy and scored ≥5 points according to the American Fertility Society criteria (1988); ② With symptoms such as reduced menstrual flow amenorrhea, periodic lower abdominal pain, infertility, or recurrent miscarriage; ③ Adult women with the desire to conceive.
- Thin endometium: ①Endometrial thickness <7mm on ovulation day or on the day of human chorionic gonadotropin (HCG) injection, or <7mm on progesterone conversion day when using conventional hormone replacement therapy, ②adult women with the desire to comceive.
- Repeated implantation failure: Women under 40 years old who have failed to achieve clinical pregnancy after transplanting at least three high-quality embryos within three fresh or frozen cycles. High-quality embryos include: Day 3 embryos (with ≥8 cells, evenly sized blastomeres, and <10% fragmentation) and blastocysts (≥3BB).
Who cannot join
- Alanine aminotransferase > 3 times the normal upper limit or estimated glomerular filtration rate (EGFR) < 90 ml/min;
- Suffering from hemorrhagic diseases (such as hemophilia) or taking anticoagulant or antiplatelet drugs;
- Suffering from serious mental illness, cardiovascular and cerebrovascular diseases and malignant tumors;
- Suffering from diabetes with poor blood sugar control or other systemic diseases;
- Drug abuse, alcoholism or drug addiction;
- Participated in other interventional clinical studies within half a year;
- Poor compliance;
- Other circumstances that are not suitable for participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
youhua Lai, +86 15925977413, jigoulunli_zy4y@163.com
About this study
Female fertility is affected by many factors, such as ovarian function, fallopian tube patency, uterine environment, and mental state, among which the ovaries and endometrium are more important. In reproductive medicine, ovarian dysfunction, poor ovarian reaction, intrauterine adhesion, recurrent implantation failure, and thin endometrium are the five most common diseases that affect fertility. These five diseases lack effective treatment, and previous studies have shown that platelet-rich plasma is promising in treating these five diseases, so it is necessary to further explore the therapeutic effect and potential mechanism.
- Conditions
- Premature Ovarian Insufficiency, Intrauterine Adhesion, Poor Ovarian Response, Repeated Implantation Failure, Thin Endometrium
- Being tested
- Platelet-Rich Plasma (PRP) Injections
- Medical subject headings
- Primary Ovarian Insufficiency, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma (PRP) InjectionsOther
Transvaginal or laparoscopic injection for ovarian diseases (Premature ovarian insufficiency and Poor ovarian response). Intrauterine perfusion or sub-endometrium injection for uterine diseases (intrauterine adhesion, thin endometrium, and repeated implantation failure)
| Study group | Role | What they receive |
|---|---|---|
| reproductive disease | Experimental | Platelet-rich Plasma injection Receives: Other: Platelet-Rich Plasma (PRP) Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events or serious adverse events
Discomfort or clinically significant abnormalities reported by patients after enrollment
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start17 Oct 2024
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645379
- Sponsor's protocol ID
- KY-2024-176
- Status last verified
- Feb 2025
- First submitted
- 7 Oct 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Platelet-rich Plasma (PRP) in Reproductive Medicine
- ClinicalTrials.gov ID
- NCT06645379
- Acronym / sponsor ID
- KY-2024-176
- Conditions
- Premature Ovarian Insufficiency, Intrauterine Adhesion, Poor Ovarian Response, Repeated Implantation Failure, Thin Endometrium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 16 Oct 2024 (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.
Female fertility is affected by many factors, such as ovarian function, fallopian tube patency, uterine environment, and mental state, among which the ovaries and endometrium are more important. In reproductive medicine, ovarian dysfunction, poor ovarian reaction, intrauterine adhesion, recurrent implantation failure, and thin endometrium are the five most common diseases that affect fertility. These five diseases lack effective treatment, and previous studies have shown that platelet-rich plasma is promising in treating these five diseases, so it is necessary to further explore the therapeutic effect and potential mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| reproductive disease | Experimental | Other: Platelet-Rich Plasma (PRP) InjectionsPlatelet-rich Plasma injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Premature ovarian insufficiency: ① Women aged >18 and <40 years old; ② Oligomenorrhea or amenorrhea for more than 4 months (excluding pregnancy); ③ Basal follicle stimulating hormone (FSH) >25IU/L (interval >4 weeks) at least 2 times, or total antral follicles (AFC) <5, or anti-Mullerian hormone (AMH) <1.1ng/mL.
- Poor ovarian response: ① Advanced age (≥40 years) or other risk factors for poor ovarian response; ② Poor ovarian response in previous IVF cycle, with ≤3 oocytes retrieved using conventional protocols; ③ Decreased ovarian reserve (antral follicle count <5~7 or anti-Müllerian hormone <0.5~1.1 ug/L). Meeting any 2 of the above 3 criteria is sufficient.
- Intrauterine adhesion: ① Diagnosed by hysteroscopy and scored ≥5 points according to the American Fertility Society criteria (1988); ② With symptoms such as reduced menstrual flow amenorrhea, periodic lower abdominal pain, infertility, or recurrent miscarriage; ③ Adult women with the desire to conceive.
- Thin endometium: ①Endometrial thickness <7mm on ovulation day or on the day of human chorionic gonadotropin (HCG) injection, or <7mm on progesterone conversion day when using conventional hormone replacement therapy, ②adult women with the desire to comceive.
- Repeated implantation failure: Women under 40 years old who have failed to achieve clinical pregnancy after transplanting at least three high-quality embryos within three fresh or frozen cycles. High-quality embryos include: Day 3 embryos (with ≥8 cells, evenly sized blastomeres, and <10% fragmentation) and blastocysts (≥3BB).
Key exclusion criteria (8 listed)
- Alanine aminotransferase > 3 times the normal upper limit or estimated glomerular filtration rate (EGFR) < 90 ml/min;
- Suffering from hemorrhagic diseases (such as hemophilia) or taking anticoagulant or antiplatelet drugs;
- Suffering from serious mental illness, cardiovascular and cerebrovascular diseases and malignant tumors;
- Suffering from diabetes with poor blood sugar control or other systemic diseases;
- Drug abuse, alcoholism or drug addiction;
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 |
|---|---|---|
| Platelet-Rich Plasma (PRP) InjectionsTransvaginal or laparoscopic injection for ovarian diseases (Premature ovarian insufficiency and Poor ovarian response). Intrauterine perfusion or sub-endometrium injection for uterine diseases (intrauterine adhesion, thin endometrium, and repeated implantation failure) | Other | reproductive disease |
Primary outcome
adverse events or serious adverse events
Time frame: From enrollment to the end of treatment at 3 months
Discomfort or clinically significant abnormalities reported by patients after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Plasma (PRP) Injections in people with Premature Ovarian Insufficiency and Intrauterine Adhesion, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
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 8 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youhua Lai (+86 15925977413, tj_lyh1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events or serious adverse events (time frame: From enrollment to the end of treatment at 3 months). 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 18 Feb 2025.