Recruiting PHASE2, PHASE3 Poor Response to Ovulation Induction

New treatment option for Poor Response to Ovulation Induction

Official title Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

ClinicalTrials.gov ID: NCT05181748

What this study is testing

What is Autologous platelet rich plasma?

Autologous platelet rich plasma is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for poor response to ovulation induction.

Also referred to as PRP.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Autologous platelet rich plasma (PRP) intraovarian infusion may improve ovarian response to controlled ovarian stimulation as well as the hormonal profile of poor ovarian response infertile women subjected to intracytoplasmic sperm injection (ICSI) treatment.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 35 to 47, women only. Healthy volunteers may be eligible.

You may be able to join if

  • Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following):
  • Age ≥ 40 years
  • AMH \< 1.1 ng/ml OR AFC \< 7
  • ≤ 3 oocytes with a conventional stimulation protocol
  • Discontinuation of any complementary/adjuvant treatment including hormone replacement and acupuncture, for at least three months prior to recruitment.

You likely can't join if

  • Any pathological disorder related to reproductive system anatomy
  • Cycle irregularities
  • Amenorrhea
  • Endometriosis
  • Adenomyosis
  • Fibroids and adhesions
See the full eligibility criteria
Who can join
  • Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following):
  • Age ≥ 40 years
  • AMH \< 1.1 ng/ml OR AFC \< 7
  • ≤ 3 oocytes with a conventional stimulation protocol
  • Discontinuation of any complementary/adjuvant treatment including hormone replacement and acupuncture, for at least three months prior to recruitment.
  • Willing to comply with study requirements
What rules you out
  • Any pathological disorder related to reproductive system anatomy
  • Cycle irregularities
  • Amenorrhea
  • Endometriosis
  • Adenomyosis
  • Fibroids and adhesions
  • Infections in reproductive system
  • Current or previous diagnosis of cancer in reproductive system
  • History of familiar cancer in reproductive system
  • Severe male factor infertility
  • Prior referral for Preimplantation Genetic Testing (PGT) -Ovarian inaccessibility -Endocrinological disorders (Hypothalamus-
  • Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
  • BMI\>30 kg/m2 or BMI\<18.5 kg/m2
  • Systematic autoimmune disorders

The study team makes the final eligibility decision.

Where it's taking place

  • Athens, Attica, Greece

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 35 years to 47 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Athens, Attica, Greece. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.