The Safety and Efficacy study of IVA technique Combined Stem Cell Therapy (IVASc) in Patients With Premature Ovarian Failure (POF)

Evaluating the effects of allogeneic transplantation of umbilical cord- derived mesenchymal stem cells combination with in vitro activation (IVA) technique on improvement of ovarian function and fertility outcomes in women with premature ovarian failure (POF)- Clinical trials phase I

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211021052828N1

Enrollment

Registered

2021-11-14

Start date

2021-12-16

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ovarian Failure (POF). Primary ovarian failure

Interventions

Intervention group: Invitro activation (IVA) and stem cell transplantation.

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Normal karyotyping female Diagnosed with Premature Ovarian Failure: Serum FSH > 20 IU/l, AMH < 0.3 ng /mL Normal TSH Agree to sign the designed consent for the study women aged 18 to 40 years old

Exclusion criteria

Exclusion criteria: Thyroid dysfunction Immunological Conditions Past history of malignancy/cemotherapy/radiotherapy Infectious diseases: HIV+, hepatitis B+, C+ Abnormal karyotype Previous surgical management of ovarian pathology Severe endometriosis Breast cancer, ovarian cancer Severe pulmonary, kidney and hematological disease, diabetes (type I,II), ... Severe anemia (Hemoglobin <8 g/dL)

Design outcomes

Primary

Measure	Time frame
Get regular periods naturally. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: consultation.;Decrease FSH serum level. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: Serum level of hormone.;Increase Estradiol serum level. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: Serum level of hormone.;Increase AMH serum level. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: Serum level of hormone.;, Increase of number and size of ovarian follicles. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: , Sonography of follicle number and size.;?????? ????? ???????. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: Sonography of endometrial thickness.;Natural conception or conceive Assisted reproductive technology (ART). Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: Consultation.	—

Measure

Time frame

Get regular periods naturally. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: consultation.;Decrease FSH serum level. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: Serum level of hormone.;Increase Estradiol serum level. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: Serum level of hormone.;Increase AMH serum level. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: Serum level of hormone.;, Increase of number and size of ovarian follicles. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: , Sonography of follicle number and size.;?????? ????? ???????. Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: Sonography of endometrial thickness.;Natural conception or conceive Assisted reproductive technology (ART). Timepoint: Before intervention and 3, 6 and 12 months after intervention. Method of measurement: Consultation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Elham Vojoudi

Guilan University of Medical Sciences

elhamvojoodi@yahoo.com+98 13 3376 4270

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026