Platelet Rich Plasma on Ovarian Reserve Parameters and Intra Cytoplasmic Sperm Injection Outcomes in Patients With Diminished Ovarian Reserve

NCT06048666 | Unknown Phase 3

• 1 other identifier: PRP in poor ovarian reserve
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of intra ovarian injection of autologous platelet rich plasma on ovarian reserve parameters and ICSI outcomes in poor ovarian reserve.

Conditions

IVF

Keywords

platelet rich plasma , poor ovarian reserve

Outcome Measures

Primary Outcomes (1)

• number of retrieved oocytes

  number of oocytes obtained in ovum pick up

  1 month of induction for ICSI trial

Study Arms (2)

Intra ovarian by platelet rich plasma

EXPERIMENTAL

intra-ovarian injection of autologous platelet rich plasma 3 months after the PRP injection,they will undergo assisted reproductive therapy with antagonist protocol followed by a dose of 450 units of FSH (Gonal F)

Biological: Intra ovarian by platelet rich plasma

control

NO INTERVENTION

they will undergo ICSI trial with antagonist protocol followed by a dose of 450 units of FSH (Gonal F)

Interventions

Intra ovarian by platelet rich plasma BIOLOGICAL

On the day of PRP infusion (within 10 days after completion of menstrual bleeding) we will take 20 cc of venous blood from each participant of group A to prepare PRP. The blood will be transferred to a tube containing sodium citrate and centrifuged at 800 RPM for 15 min and 2000 RPM for 5 min in two stages, respectively. Then, by discarding part of the plasma, PRP will be prepared with a final concentration of one million platelets per microliter. The PRP will be injected into the ovary under spinal anesthesia and a transvaginal ultrasound guide.

Intra ovarian by platelet rich plasma

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women under the age of 40.
• have been infertile for more than a year
• have had at least one previous unsuccessful (or cancelled) IVF cycle.
• having one of the criteria of poor ovarian response including anti mullerian hormone (AMH) level \<1.1 ng /ml ,the antral follicle count of two ovaries in vaginal ultrasound \<7 .

You may not qualify if:

• pregnancy(ruled out and documented before PRP injection) . Hydrosalpinex,uterine malformations and abnormal uterine cavity.
• Partner with severe male factor
• Ongoing malignancy.
• Chronic pelvic pain
• A history of major lower abdomen surgeries that resulted in pelvic adhesions.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

Central Study Contacts

Beni-suef University

CONTACT

082 2318605; fom@med.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 21, 2023
• Study Start: October 30, 2023
• Primary Completion: March 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

EG (1)