Ovarian PRP Injection in Women With POR

NCT05601193 | Unknown

• 1 other identifier: 2022ZSLYEC-495
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Poor Ovarian Response

Keywords

Poor Ovarian Response; Platelet-Rich Plasma

Outcome Measures

Primary Outcomes (1)

• number of oocytes retrieval

  The number of oocytes retrieval under the same ovarian stimulation protocol before and after PRP injection

  2 years

Secondary Outcomes (2)

• Ovarian function in DOR patients before and after PRP injection.

  2 years

• Outcomes of IVF in DOR patients before and after PRP injection under the same ovarian stimulation protocol.

  3 years

Other Outcomes (1)

• Functional experiments of follicular fluid and granulosa cells before and after PRP injection

  1 year

Study Arms (2)

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

Other: autologous platelet-rich plasma

Control group

NO INTERVENTION

No intervention

Interventions

autologous platelet-rich plasma OTHER

autologous PRP preparation was done by segregation of PRP following the centrifugation

PRP group

Eligibility Criteria

• Age: 20 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Reproductive Medicine Research Center, the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Xiaoyan Liang

CONTACT

86 020-38250752; liangxy2@mail.sysu.edu.cn

Qian Li

CONTACT

15917369026; liqian226@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 1, 2022
• Study Start: October 27, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

CN (1)