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Completed
NCT05703308
Menstrual Blood Stem Cells in Poor Ovarian Responders
Conditions: Poor Ovarian Response, Infertility, Female
Sex: Female
Ages: 25 Years – 45 Years
Phase: PHASE3
Enrollment: 180
Sponsor: Avicenna Research Institute
Location: Iran, Islamic Republic of
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.
Eligibility Criteria
Inclusion Criteria: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-ETNormal thyroid hormones (TSH and FT4)Normal level of prolactin,Normal level of fasting blood sugarNormal Liver tests (SGOT, SGPT)Normal level of BUN, creatinineNegative Infectious tests (HIV, HCV, HBS Ag, VDRL)Normal coagulation factors (PT, PTT, BT, CT)Normal serum levels of sodium, potassium, calcium, phosphorusNegative history of endometrioma or other ovarian cystsNegative history of previous ovarian surgeryNegative history of cancerNegative history of a known autoimmune disorder.Exclusion Criteria:Positive history of hydrosalpinx or anatomical uterine disorders (In vaginal sonography or HSG)Severe male factors of their husbands (count <15 million/ml)
Source: ClinicalTrials.gov (NCT05703308). StuddyBuddy aggregates publicly available trial information.
