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

Effect of Intra-ovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve Parameters and Intra Cytoplasmic Sperm Injection Outcomes in Patients With Diminished Ovarian Reserve

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.

Study Overview

• Status: Not yet recruiting
• Conditions: IVF
• Intervention / Treatment: Biological: Intra ovarian by platelet rich plasma

Detailed Description

fifty_six infertile women suffering from poor ovarian reserve &following up at IVF Unit of Beni_suef University hospital. , and they fulfilled inclusion and exclusion criteria. they will be classlfied into two groups: Group A (study group) (involve 28 patient ):will be injected intra ovarian by platelet rich plasma Group B (control group) (involve 28 patient): will not be injected intra ovarian by platelet rich Plasma

The researcher will introduce himself to all participants included in this study and requested that they participate after explaining the purpose of the study. All participants will be given detailed information about the study's goal and predicted advantages. All participants will give their informed verbal agreement, and the data will be kept confidential. All patients will be subjected to:

Complete history was taken with special emphasis on:

Personal ,past,family&surgical history. Menstrual historyObstetric history

Clinical examination:

Physical examination included General examination: Weight, Height, BMI, Abdominal examination , Local (Pelvic) examination

Ultrasound examination:

The women will be in lithotomy position with an empty bladder. On day 2 of the menstrual cycle or withdrawal bleed, a sterile vaginal speculum has been introduced, and a TV ultrasonography probe (7.0-MH endo-vaginal probe) has been placed in the vagina roughly 1 cm away from the cervix to evaluate the volume of the ovary and antral follicle counts (AFC).

Investigations:

General (CBC, urinalysis, Random blood sugar) when needed. Specific: Hormonal profile in all patients of the study, the following were obtained prior to the procedure: Anti-Mullerian hormone (AMH). FSH, Estradiol.

• PRP preparation and time of injection 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.
• Patien assessment and Follow up. patients injected with PRP will be managed expectantly for 6 weeks to allow spontaneous pregnancy, at the beginning of second menstrual cycle AMH, FSH, AFC will be reassessed.
• 3months after the PRP injection, all women considered poor responders (2groups)will undergo assisted reproductive therapy with antagonist protocol followed by a dose of 450 units of FSH (Gonal F, CinnaGen, Iran). Six days after gonadotropin therapy, vaginal ultrasound will be performed to measure follicle diameter. Once the follicular size is 12 mm, the GnRH antagonist (Cetrorelix, Merck-Serono, Germany) will begin, and gonadotropin continued. When at least two dominant follicles reach the diameter of 18 mm on ultrasound, ovulation will be stimulated using 10,000 units of HCG, and oocyte retrieval will be performed under general anesthesia 34 to 36 h after the HCG injection and the two groups will be compared in terms of the outcomes such as duration of stimulation dosage of gonadotrophine serum of estradiol level on the triggering day ,number and quality of oocytes and embryons and clinical pregnancy

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Beni-suef University; Phone Number: 02 082 2318605; Email: fom@med.bsu.edu.eg

Study Locations

• Egypt
  • Beni Suef
    • Banī Suwayf, Beni Suef, Egypt, 62521
      • Beni-suef university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 .

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra ovarian by platelet rich plasma; 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; 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.
No Intervention: control; they will undergo ICSI trial with antagonist protocol followed by a dose of 450 units of FSH (Gonal F)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of retrieved oocytes	number of oocytes obtained in ovum pick up	1 month of induction for ICSI trial

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: September 16, 2023
• First Submitted That Met QC Criteria: September 16, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: platelet rich plasma , poor ovarian reserve
• Other Study ID Numbers: PRP in poor ovarian reserve

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No