MedTrace Logo

Menstrual Blood Stem Cells in Poor Ovarian Responders

NCT05703308 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-01-30

No results posted yet for this study

Summary

In this controlled trial, poor ovarian responder women will be treated with transplantation of autologous menstrual blood stem cells. The investigators will attempt to assess the safety and efficacy of this procedure for the treatment of infertility in POR patients compared to control group.

Conditions

  • Poor Ovarian Response
  • Infertility, Female

Interventions

BIOLOGICAL

Autologous Menstrual Blood Stem Cells

The menstrual blood of patients in the MenSCs treatment group was collected in sterile menstrual cups on the second day of menstruation, and directly transferred to a class B clean room for MSC isolation and culture. All cell quality control studies were performed prior to the International Conference of Harmonization Q2 (ICH Q2) guidelines. The density of the final product was 20×106 cells/ml. 150 μl of the prepared suspension was injected intravaginally into each ovary of the patient under general anaesthesia

Sponsors & Collaborators

  • Avicenna Research Institute

    lead OTHER

Principal Investigators

  • Simin Zafardoust, MD · Nanbiotechnology Research Center Avicenna Research Institute, ACECR, Tehran, Iran.

  • Somaieh Kazemnejad · Nanbiotechnology Research Center Avicenna Research Institute, ACECR, Tehran, Iran.

  • Mina Fathi Kazerooni, MD, PhD · Nanbiotechnology Research Center Avicenna Research Institute, ACECR, Tehran, Iran.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-21
Primary Completion
2021-09-22
Completion
2022-10-22

Countries

  • Iran

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05703308 on ClinicalTrials.gov