Poor Ovarian ResponseNCT05601193
Ovarian PRP Injection in Women With POR
A study testing autologous platelet-rich plasma in people with Poor Ovarian Response, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Patients with poor ovarian response (POR）is considered one of most challenging tasks in artificial reproductive treatment (ART). Several retrospective studies have shown that platelet-rich plasma (PRP) is one of the proposed therapeutic strategies for women with POR. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Poor Ovarian Response
- What is being tested?
- autologous platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2022to Oct 2025
- 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 20 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1) Women less than 43 years old and undergo IVF/ICSI; 2) AMH < 1.1 and the number of follicles in bilateral antrum < 7; 3) those who have obtained less than or equal to 3 follicles in conventional controlled ovulation cycle or whose diameter ≥ 14mm on the trigger day; or have a previous history of ovarian cyst removal; if the woman is less than 40 years old, she needs to meet the inclusion criteria 2 and 3 at the same time. If you are 40 years old or older, you can join the group if you meet the inclusion criteria 2 or 3.
Who cannot join
- 1) patients with clear indications or plans to undergo pre-embryo transfer genetic diagnosis (PGD) and preimplantation genetic screening (PGS); 2) patients with recurrent abortion who had more than 2 consecutive spontaneous abortions (including biochemical pregnancy); 3) men with azoospermia who underwent microsemen extraction; 4) benign ovarian cysts (endometriosis cyst, teratoma, etc.) found by B-ultrasound; 5) women with heart, liver and kidney insufficiency. 6) one of the husband and wife has chromosome abnormality; 7) the history of malignant tumor of the woman or the hereditary family history of the husband and wife 8) uterine anatomical abnormalities (including uterine adhesion, endometrial polyps, submucous myoma, uterine mediastinum, etc.) 9) untreated hydrosalpinx 10) uncontrolled endocrine abnormalities, including thyroid dysfunction, diabetes, etc. 11) other reasons that the researchers believe are not appropriate to participate in this study, such as positive for syphilis or HIV.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive Medicine Research Center, the Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Xiaoyan Liang, 86 020-38250752, liangxy2@mail.sysu.edu.cn
Qian Li, 15917369026, liqian226@126.com
About this study
Official title: Effect of Ovarian Injection of Autologous Platelet-Rich Plasma on the Pregnancy Outcome of IVF/ICSI in Patients With Poor Ovarian Response: A Prospective Randomized Controlled Study
Patients with poor ovarian response (POR）is considered one of most challenging tasks in artificial reproductive treatment (ART). Several retrospective studies have shown that platelet-rich plasma (PRP) is one of the proposed therapeutic strategies for women with POR. However, prospective randomized controlled trials are still lacking. This study aimed to evaluate the effect on intraovarian injection of autologous PRP in poor ovarian reserve prospectively.
Read the detailed description
It will be divided two groups of POR patients according to the treatment itself. One group was treated by intraovarian injection of autologous PRP, and the other was control. It will detect the function of ovarian reserve and IVF outcomes before and after treatment in both two groups. In addition, granulosa cells and follicular fluid before and after injection were collected for functional exploration experiments.
- Conditions
- Poor Ovarian Response
- Being tested
- autologous platelet-rich plasma
- Keywords
- Poor Ovarian Response; Platelet-Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous platelet-rich plasmaOther
autologous PRP preparation was done by segregation of PRP following the centrifugation
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | Experimental: autologous PRP Bilateral ovaries autologous PRP injection under transvaginal ultrasound guidance. 3ml on each ovary.Once a month. two consecutive injections Receives: Other: autologous platelet-rich plasma |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocytes retrieval
The number of oocytes retrieval under the same ovarian stimulation protocol before and after PRP injection
Measured: 2 years
Secondary outcomes (2)
Ovarian function in DOR patients before and after PRP injection.
Anti-müllerian Hormone (AMH) serum level, Follicle Stimulating Hormone (FSH) serum level, Estradiol (E2) serum level level on menstrual day 2/3
Measured: 2 years
Outcomes of IVF in DOR patients before and after PRP injection under the same ovarian stimulation protocol.
The number of oocyte retrieval, fertilization rate , blastocyst formation rate, implantation rate, incidence of clinical pregnancy rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start27 Oct 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Ovarian ResponseStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601193
- Sponsor's protocol ID
- 2022ZSLYEC-495
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ovarian Injection of Autologous Platelet-Rich Plasma on the Pregnancy Outcome of IVF/ICSI in Patients With Poor Ovarian Response: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05601193
- Acronym / sponsor ID
- 2022ZSLYEC-495
- Conditions
- Poor Ovarian Response
- Keywords
- Poor Ovarian Response; Platelet-Rich Plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 1 Nov 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.
Patients with poor ovarian response (POR）is considered one of most challenging tasks in artificial reproductive treatment (ART). Several retrospective studies have shown that platelet-rich plasma (PRP) is one of the proposed therapeutic strategies for women with POR. However, prospective randomized controlled trials are still lacking. This study aimed to evaluate the effect on intraovarian injection of autologous PRP in poor ovarian reserve prospectively.
Detailed description
It will be divided two groups of POR patients according to the treatment itself. One group was treated by intraovarian injection of autologous PRP, and the other was control. It will detect the function of ovarian reserve and IVF outcomes before and after treatment in both two groups. In addition, granulosa cells and follicular fluid before and after injection were collected for functional exploration experiments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Other: autologous platelet-rich plasmaExperimental: autologous PRP Bilateral ovaries autologous PRP injection under transvaginal ultrasound guidance. 3ml on each ovary.Once a month. two consecutive injections |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) Women less than 43 years old and undergo IVF/ICSI; 2) AMH < 1.1 and the number of follicles in bilateral antrum < 7; 3) those who have obtained less than or equal to 3 follicles in conventional controlled ovulation cycle or whose diameter ≥ 14mm on the trigger day; or have a previous history of ovarian cyst removal; if the woman is less than 40 years old, she needs to meet the inclusion criteria 2 and 3 at the same time. If you are 40 years old or older, you can join the group if you meet the inclusion criteria 2 or 3.
Key exclusion criteria (1 listed)
- 1) patients with clear indications or plans to undergo pre-embryo transfer genetic diagnosis (PGD) and preimplantation genetic screening (PGS); 2) patients with recurrent abortion who had more than 2 consecutive spontaneous abortions (including biochemical pregnancy); 3) men with azoospermia who underwent microsemen extraction; 4) benign ovarian cysts (endometriosis cyst, teratoma, etc.) found by B-ultrasound; 5) women with heart, liver and kidney insufficiency. 6) one of the husband and wife has chromosome abnormality; 7) the history of malignant tumor of the woman or the hereditary family history of the husband and wife 8) uterine anatomical abnormalities (including uterine adhesion, endometrial polyps, submucous myoma, uterine mediastinum, etc.) 9) untreated hydrosalpinx 10) uncontrolled endocrine abnormalities, including thyroid dysfunction, diabetes, etc. 11) other reasons that the researchers believe are not appropriate to participate in this study, such as positive for syphilis or HIV.
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 plasmaautologous PRP preparation was done by segregation of PRP following the centrifugation | Other | PRP group |
Primary outcome
number of oocytes retrieval
Time frame: 2 years
The number of oocytes retrieval under the same ovarian stimulation protocol before and after PRP injection
2 secondary outcomes
Ovarian function in DOR patients before and after PRP injection.
Time frame: 2 years
Outcomes of IVF in DOR patients before and after PRP injection under the same ovarian stimulation protocol.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
Related trials for Poor Ovarian Response
RecruitingObservational study
Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment
Poor Ovarian Response, Ovarian Reactivation
RecruitingPhase 3
Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST)
Low Ovarian Reserve, Poor Ovarian Response
RecruitingPhase 2/3
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Poor Response to Ovulation Induction, Infertility, Female
Not yet recruiting
A RCT Study on Autologous Cell Injection Into the Ovaries of Patients With POR
Poor Ovarian Response
Not yet recruiting
A RCT Study on Autologous PRP Injection in Patients With POR
Poor Ovarian Response, PRP Injection
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.
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 in people with Poor Ovarian Response, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 1 inclusion and 1 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 1 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Liang (86 020-38250752, liangxy2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of oocytes retrieval (time frame: 2 years). 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 1 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.