Menstrual Blood Stem Cells in Poor Ovarian Responders
Outcome of Pregnancy in Poor Ovarian Responders by Intraovarian Administration of Autologous Menstrual Blood Derived-Mesenchymal Stromal Cells
1 other identifier
interventional
180
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2022
CompletedFirst Submitted
Initial submission to the registry
January 15, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedJanuary 30, 2023
January 1, 2023
1.3 years
January 15, 2023
January 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Spontaneous pregnancy rate
Number of participants that establish a spontaneous clinical pregnancy after stem cell injection
3 months after stem cell injection
Pregnancy rate after ICSI
Number of participants that establish a clinical pregnancy after embryo transfer
4 weeks after embryo transfer
Secondary Outcomes (9)
Hormone levels
2 and 4 months after stem cell injection
Number of oocytes
Day 0 after follicle puncture
Number of MII oocytes
Day 0 after follicle puncture
Number of embryos
Day 3-5 after follicle puncture
Number of high quality embryos number
Day 3-5 after follicle puncture
- +4 more secondary outcomes
Study Arms (2)
MenSCs group
EXPERIMENTALStudy group, treated with autologous intra-ovarian MenSCs injection and monitored for spontaneous pregnancy for 3 months after intervention. ICSI was used in cases where the pregnancy did not occur naturally.
ICSI group
NO INTERVENTIONControl group, monitored for spontaneous pregnancy for 3 months after their last ovarian stimulation for ICSI or IVF. ICSI was used in cases where the pregnancy did not occur naturally.
Interventions
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
Eligibility Criteria
You may qualify if:
- Serum AMH \< 0.1 ng/ml (at the screening visit and in the absence of OC or sex-steroid intake)
- Antral follicular count (AFC) in both ovaries \< 4 (at screening visit and in the absence of OC or sex-steroid intake)
- Positive history of at least1 standard previous IVF-ET or ICSI-ET
- Normal thyroid hormones (TSH and FT4)
- Normal level of prolactin,
- Normal level of fasting blood sugar
- Normal Liver tests (SGOT, SGPT)
- Normal level of BUN, creatinine
- Negative Infectious tests (HIV, HCV, HBS Ag, VDRL)
- Normal coagulation factors (PT, PTT, BT, CT)
- Normal serum levels of sodium, potassium, calcium, phosphorus
- Negative history of endometrioma or other ovarian cysts
- Negative history of previous ovarian surgery
- Negative history of cancer
- Negative history of a known autoimmune disorder.
You may not qualify if:
- Positive history of hydrosalpinx or anatomical uterine disorders (In vaginal sonography or HSG)
- Severe male factors of their husbands (count \<15 million/ml)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Avicenna Research Institute
Tehran, Iran
Related Publications (1)
Zafardoust S, Kazemnejad S, Fathi-Kazerooni M, Darzi M, Sadeghi MR, Sadeghi Tabar A, Sehat Z. The effects of intraovarian injection of autologous menstrual blood-derived mesenchymal stromal cells on pregnancy outcomes in women with poor ovarian response. Stem Cell Res Ther. 2023 Nov 15;14(1):332. doi: 10.1186/s13287-023-03568-1.
PMID: 37968668DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Simin Zafardoust, MD
Nanbiotechnology Research Center Avicenna Research Institute, ACECR, Tehran, Iran.
- STUDY CHAIR
Somaieh Kazemnejad
Nanbiotechnology Research Center Avicenna Research Institute, ACECR, Tehran, Iran.
- PRINCIPAL INVESTIGATOR
Mina Fathi Kazerooni, MD, PhD
Nanbiotechnology Research Center Avicenna Research Institute, ACECR, Tehran, Iran.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2023
First Posted
January 30, 2023
Study Start
June 21, 2020
Primary Completion
September 22, 2021
Study Completion
October 22, 2022
Last Updated
January 30, 2023
Record last verified: 2023-01