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AzTrials

Poor Ovarian ResponseNCT07282314

A RCT Study on Autologous PRP Injection in Patients With POR

A study testing PRP injection in people with Poor Ovarian Response and PRP Injection, run by Peking University Third Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Poor ovarian response (POR) is a pathological condition where the ovaries do not respond well to the stimulation of gonadotropins. It is mainly characterized by a low number of developing follicles, a high cancellation rate of the ovarian stimulation cycle, a small number of retrieved oocytes, and a low clinical… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Poor Ovarian Response, PRP Injection
What is being tested?
PRP injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
No sites listed yet
Study dates
15 Dec 2025to 1 Nov 2029
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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women who have fertility requirements and are seeking IVF treatment at the Reproductive Medicine Center of Peking University Third Hospital
  • Age ≤ 45 years old, infertility duration ≥ 1 year
  • Meeting the diagnostic criteria for POI or the Poseidon diagnostic criteria for POR
  • Previous controlled ovarian stimulation resulted in no more than 3 oocytes retrieved and/or no transplantable embryos and/or previous embryo implantation failure ≥ 2 times
  • Uterus and bilateral adnexa are intact
  • BMI 18.5 - 29 kg/m²
  • Participants must have given informed consent for this study and voluntarily signed a written informed consent form.

Who cannot join

  • Congenital abnormalities of reproductive organs
  • Septicemia, platelet dysfunction syndrome and severe thrombocytopenia and other coagulation disorders or other hematological diseases
  • Suffering from autoimmune diseases or other endocrine disorders, with abnormal thyroid function and uncontrolled condition
  • Having a mass in the adnexal area with an unclear benign or malignant nature
  • Complicated with severe cardiovascular and cerebrovascular diseases, malignant tumors, hematological diseases and mental disorders, patients with impaired function of important organs
  • Those who have used systemic corticosteroids within the last 2 weeks, or used antiplatelet drugs such as aspirin within the last 48 hours
  • In the acute inflammatory stage
  • Those with a history of venous thrombosis or pulmonary embolism during the screening period

About this study

Official title: A Randomized Controlled Study on Autologous Platelet-rich Plasma Injection in Patients With Poor Ovarian Response

Poor ovarian response (POR) is a pathological condition where the ovaries do not respond well to the stimulation of gonadotropins. It is mainly characterized by a low number of developing follicles, a high cancellation rate of the ovarian stimulation cycle, a small number of retrieved oocytes, and a low clinical pregnancy rate. Premature ovarian insufficiency (POI) is a special type of this condition and is one of the most difficult infertility diseases to treat. The incidence of POR and POI in reproductive-aged women in China is increasing year by year, making them key and challenging issues in reproductive medicine. Novel local ovarian cell therapy can improve the microenvironment for follicle development, promote the development and ovulation of "dormant" primordial follicles, and improve the quality of oocytes. This study intends to conduct a prospective randomized controlled trial to evaluate the safety and efficacy of autologous platelet-rich plasma (PRP) local injection therapy for improving ovarian reserve and IVF-ET outcomes in patients with POR and POI. This study is expected to improve the fertility of POR patients from the perspective of autologous cell therapy. The autologous PRP local injection technique does not involve ethical barriers, is easy to standardize the diagnosis and treatment process and operation system, and is suitable for clinical translation and promotion.

Being tested
PRP injection
Keywords
poor ovarian response, autologous platelet-rich plasma, Premature ovarian insufficiency
Medical subject headings
Primary Ovarian Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRP injectionDevice

    Under ultrasound guidance, through vaginal puncture, PRP was injected subcutaneously into the ovarian cortex on both sides. There were 3 injection points on each side of the ovary, with 0.5ml injected at each point. The total injection volume for each side of the ovary was 1.5ml. The injection was carried out for 1 to 3 consecutive cycles.

Study groups in NCT07282314
Study groupRoleWhat they receive
PRP groupExperimentalUnder ultrasound guidance, through vaginal puncture, PRP was injected subcutaneously into the ovarian cortex on both sides. There were 3 injection points on each side of the ovary, with 0.5ml injected at each point. The total injection volume for each side of the ovary was 1.5ml. The injection was carried out for 1 to 3 consecutive cycles.
Receives: Device: PRP injection
Control GroupNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of retrieved oocytes

    The treatment is considered successful if the number of retrieved oocytes increases by ≥ 2 after the treatment. The effective rate of treatment = (number of effective treatment cycles) / (total number of cycles) × 100%

    Measured: 6 months

Secondary outcomes (3)

  1. Blood anti-Müllerian hormone (AMH) level

    Treatment is considered successful if the AMH level rises continuously for two consecutive times. The effective rate of treatment = (number of effective cases) / (total number of cases) × 100%

    Measured: 6 months

  2. Number of antral follicles

    The treatment is considered successful if the number of antral follicles in both ovaries increases by ≥ 2 after treatment. The effective rate of treatment = (number of treated cases with effective results) / (total number of treated cases) × 100%

    Measured: 6 months

  3. clinical pregnancy rate

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start15 Dec 2025 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07282314
Sponsor's protocol ID
IRB00006761-M20250889
Status last verified
Dec 2025
First submitted
2 Dec 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PRP injection in people with Poor Ovarian Response and PRP Injection, run by Peking University Third Hospital.

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 7 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: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of retrieved oocytes (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07282314.

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 15 Dec 2025.

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