NCT05703308

Menstrual Blood Stem Cells in Poor Ovarian Responders

Completed Phase 3 Last updated 30 January 2023

What this trial tests

Phase 3 trial testing Autologous Menstrual Blood Stem Cells in Poor Ovarian Response in 180 participants. Completed in 22 October 2022.

Timeline

21 June 2020

Primary endpoint
22 September 2021

22 October 2022

Quick facts

Lead sponsor	Avicenna Research Institute
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	180
Start date	21 June 2020
Primary completion	22 September 2021
Estimated completion	22 October 2022
Sites	1 location across Iran

Drugs / interventions tested

• Autologous Menstrual Blood Stem Cells — full drug profile →

Conditions studied

• Poor Ovarian Response — all drugs for Poor Ovarian Response →
• Infertility, Female — all drugs for Infertility, Female →

Sponsor

Avicenna Research Institute

Who can join

Adults 25 to 45, female only, with Poor Ovarian Response or Infertility, Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effects of intraovarian injection of autologous menstrual blood-derived mesenchymal stromal cells on pregnancy outcomes in women with poor ovarian response.
   Zafardoust S, Kazemnejad S, Fathi-Kazerooni M, Darzi M, et al · · 2023 · cited 14× · PMID 37968668 · DOI 10.1186/s13287-023-03568-1
2. Stem cell treatments for female reproductive disorders: a comprehensive review.
   Nair R, Agarwal P, Gadre MA, Vasanthan KS, et al · · 2025 · cited 2× · PMID 40708035 · DOI 10.1186/s13048-025-01750-y
3. Intra-ovarian injection of autologous menstrual blood-derived-mesenchymal stromal cells: a safe and promising method to improve pregnancy rate in poor ovarian responders.
   Zafardoust S, Didar H, Ganagard MG, Tavakoli M, et al · · 2025 · cited 2× · PMID 40221741 · DOI 10.1186/s13287-025-04278-6
4. Precision medicine in premature ovarian insufficiency: a focus on the precision therapeutic strategies for mesenchymal stem cells.
   Wang R, Liu F, Liao Q, Wu J, et al · · 2025 · PMID 40671085 · DOI 10.1186/s13287-025-04512-1
5. The Effects of Intraovarian Injection of Autologous Menstrual Blood-Derived Mesenchymal Stromal Cells on Pregnancy Outcomes in Women with Poor Ovarian Response
   Zafardoust S, Kazemnejad S, Fathi-Kazerooni M, Darzi M, et al · · 2023 · DOI 10.21203/rs.3.rs-2604303/v1