- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05601193
Ovarian PRP Injection in Women With POR
October 27, 2022 updated by: Sixth Affiliated Hospital, Sun Yat-sen University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
390
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
- Name: Xiaoyan Liang
- Phone Number: 86 020-38250752
- Email: liangxy2@mail.sysu.edu.cn
Study Contact Backup
- Name: Qian Li
- Phone Number: 15917369026
- Email: liqian226@126.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Reproductive Medicine Research Center, the Sixth Affiliated Hospital of Sun Yat-sen University
-
Contact:
- Xiaoyan Liang
- Phone Number: 86 020-38250752
- Email: liangxy2@mail.sysu.edu.cn
-
Contact:
- Qian Li
- Phone Number: 15917369026
- Email: liqian226@126.com
-
-
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
20 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
No intervention
|
|
Experimental: PRP group
Experimental: autologous PRP Bilateral ovaries autologous PRP injection under transvaginal ultrasound guidance.
3ml on each ovary.Once a month.
two consecutive injections
|
autologous PRP preparation was done by segregation of PRP following the centrifugation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ovarian function in DOR patients before and after PRP injection.
Time Frame: 2 years
|
Anti-müllerian Hormone (AMH) serum level, Follicle Stimulating Hormone (FSH) serum level, Estradiol (E2) serum level level on menstrual day 2/3
|
2 years
|
Outcomes of IVF in DOR patients before and after PRP injection under the same ovarian stimulation protocol.
Time Frame: 3 years
|
The number of oocyte retrieval, fertilization rate , blastocyst formation rate, implantation rate, incidence of clinical pregnancy rate
|
3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional experiments of follicular fluid and granulosa cells before and after PRP injection
Time Frame: 1 year
|
Changes of hormone/ RNA/ protein / growth factor expression in follicular fluid and granulosa cells before and after PRP injection
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
October 27, 2022
Primary Completion (Anticipated)
October 1, 2024
Study Completion (Anticipated)
October 1, 2025
Study Registration Dates
First Submitted
October 27, 2022
First Submitted That Met QC Criteria
October 27, 2022
First Posted (Actual)
November 1, 2022
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 27, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2022ZSLYEC-495
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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