Ovarian Injection of PRP (Platelet -Rich Plasma) Vs Normal Saline in Premature Ovarian Insufficiency

NCT04922398 | Unknown Phase 1

• 1 other identifier: Hawaa-9
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

60 cases with premature ovarian insufficiency will be randomized to either receive PRP or saline injection in their ovaries. Then follow up by hormonal \& ultrasound \& clinically to monitor any changes

Conditions

Premature Ovarian Failure

Keywords

premature ovarian failure; poor responders; poor ovarian reserve; PRP

Outcome Measures

Primary Outcomes (6)

• FSH hormonal changes

  The changes in the hormones at day 3 of the menstrual cycle: FSH monitored

  3rd day of the 3rd menstrual cycle after the procedure

• vaginal ultrasound monitoring of the ovaries

  monitor the number of antral follicles.

  3rd day of the 3rd menstrual cycle after the procedure

• clinical follow up

  changes in the menstrual cycle by history taking \& questionnaire

  3rd day of the 3rd menstrual cycle after the procedure

• LH hormonal changes

  serum LH at day 3 of the menstrual cycle

  3rd day of the 3rd menstrual cycle after the procedure

• E2 hormonal changes

  serum E2 at day 3 of the menstrual cycle

  3rd day of the 3rd menstrual cycle after the procedure

• AMH hormonal changes

  serum AMH

  3rd day of the 3rd menstrual cycle after the procedure

Study Arms (2)

Group A: PRP group

ACTIVE COMPARATOR

Preparation of PRP sample fro the patient own blood then the volume immediately above the erythrocyte layer was collected. Calcium gluconate in conc. 1:9 will be used as an activator. After activation, in a period less than 2 min, approximately 4 ml of the PRP will be injected into each ovary by TVUS.

Biological: platelet rich plasma

Group B: saline group

PLACEBO COMPARATOR

consists of 30 patients, who will receive 4 ml of a normal saline inj. 0.9% Nacl. then injected into each ovary by TVUS.

Drug: Normal saline

Interventions

platelet rich plasma BIOLOGICAL

blood will be withdrawn from the patient then separation of the platelet rich layer and then injection in the ovary

Group A: PRP group

Normal saline DRUG

0.9% normal saline will be injected in each ovary

Also known as: saline

Group B: saline group

Eligibility Criteria

• Age: 20 Years - 42 Years
• Gender Eligibility Details: only in female patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• PORs who meet at least two of the following three Bologna criteria
• AMH: 0.1-1 ng/ml.

You may not qualify if:

• ovarian insufficiency due to gonadal dysgenesis and -
• chromosomal abnormalities,
• immunoglobulin A deficiency,
• the use of anticoagulants,
• psychotropic medicaments,
• psychiatric disorders,
• carcinomas or
• a history of chronic pelvic pain.
• Women with present infection,
• haemoglobin lower than 11 g/L or
• platelets lower than 150 x 10ʒ/μL were excluded from the study.

Sponsors & Collaborators

• Ahmed Saad: lead
• Hawaa Fertility Center: collaborator

Study Sites (1)

Benha University

Banhā, Qalyubia Governorate, 13512, Egypt

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mohamed F Elsherbiny, phd.MD

  Professor of OB & GYN

  STUDY DIRECTOR

Central Study Contacts

Ahmed S Saad, phd, MD

CONTACT

01221709989; drahmedsaad@live.com

Mohamed F Elsherbiny, phd.MD

CONTACT

01094070920; mohfarag171@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of obstetrics & gynecology

Model Details: 60 patients with premature ovarian failure will be divided into 2 groups. The group A consists of 30 patients, who will receive a PRP (autologous platelet-rich plasma injection) with activation with calcium chloride. The group B consists of 30 patients, who will receive a normal saline inj. 0.9% Nacl.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 10, 2021
• Study Start: June 20, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months
• Access Criteria: 6 months

Locations

EG (1)