Autologous Platelet-rich Plasma to Improve Responsiveness and Embryo Quality in Patients With Poor Ovarian Response

NCT05105724 | Unknown Phase 2 DMC

• 1 other identifier: SZ-2019-PRP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a prospective randomized controlled trial. Patients with POR who were aged \<40 years and underwent IVF/ICSI with assisted ovulation induction at our hospital were enrolled in the study. After randomization using Excel (Microsoft Corporation, Albuquerque, NM, USA), these patients were divided into two groups. Group A was the experimental group, wherein ovarian injections of PRP were administered to the patients, and group B was the control group, wherein no ovarian puncture or injection was used in the patients.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• number of oocytes retrieved

  When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 1,000 U HCG as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of oocytes retrieved was recorded.

  30 days after PRP injected

Study Arms (2)

PRP

EXPERIMENTAL

ovarian injections of PRP were administered to the patients

Biological: PRP

No ovarian puncture or injection

NO INTERVENTION

no ovarian puncture or injection was used in the patients

Interventions

PRP BIOLOGICAL

PRP was prepared using double centrifugation of the patient's autologous whole blood, and 400 µL of PRP was injected via vaginal puncture into the ovarian parenchyma.

PRP

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥20 years and \<40 years;
• Underwent at least one IVF/ICSI ovulation induction cycle at our center and with a number of retrieved oocytes of ≤3;
• Total antral follicular count of \<5-7 or AMH levels of \<0.5-1.1 μg/L.

You may not qualify if:

• Chromosomal abnormalities in either parent;
• Acute infectious diseases, endocrine metabolic diseases, and other such conditions;
• Underwent surgery for borderline ovarian cancer or malignant tumors;
• Abnormal uterine development, uterine adhesions, or other untreated endometrial lesions;
• Factors affecting oocyte retrieval or ovarian injections, such as ovarian cysts of ≥3 cm, ovarian endometriosis cysts, severe pelvic adhesions, and poor visualization of ovarian positions;
• Conditions affecting the pregnancy outcome, such as untreated hydrosalpinx, hysteromyoma of ≥4 cm, adenomyosis, and stage III-IV endometriosis;
• Azoospermia or severe oligospermia and teratozoospermia in the male partner;
• Participated in another investigational trial within the previous year;
• Allergies to blood products.

Sponsors & Collaborators

• Nanjing University: lead

Study Sites (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Haixiang Sun, PhD

  The affiliated Drum Towel Hospital of Nanjing University Medical School

  STUDY DIRECTOR

Central Study Contacts

Yue Jiang, PhD

CONTACT

025-83106666; jiangyue85@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Reproductive Medicine Center of The Affiliated Drum Tower Hospital of Nanjing University Medical School

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: November 3, 2021
• Study Start: July 20, 2019
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

CN (1)