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Tests treatment safety and results for Premature Ovarian Insufficiency
Official title Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
ClinicalTrials.gov ID: NCT07115082
What this study is testing
What is Climen 21 Tablets?
Climen 21 Tablets is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for premature ovarian insufficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 40, women only
You may be able to join if
- The intention of pregnant women aged \>= 20 and \< 40, with normal karyotype;
- Oligo/amenorrhea for at least 4 months;
- Elevated FSH level \>25 IU/l on two occasions \>4 weeks apart;
- Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months;
- Voluntary participation in the study with signed informed consent;
You likely can't join if
- Unable to follow the treatment observation process required by the trial;
- Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure;
- With breast, uterine, ovarian tumors, or any other benign or malignant tumors;
- Allergic history to drugs or any other things;
- Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs.
- Have undergone ovariectomy or have organic gynaecological diseases.
See the full eligibility criteria
- The intention of pregnant women aged \>= 20 and \< 40, with normal karyotype;
- Oligo/amenorrhea for at least 4 months;
- Elevated FSH level \>25 IU/l on two occasions \>4 weeks apart;
- Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months;
- Voluntary participation in the study with signed informed consent;
- Unable to follow the treatment observation process required by the trial;
- Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure;
- With breast, uterine, ovarian tumors, or any other benign or malignant tumors;
- Allergic history to drugs or any other things;
- Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs.
- Have undergone ovariectomy or have organic gynaecological diseases.
- Presence of other gynaecological endocrine diseases such as polycystic ovary syndrome.
- Severe functional impairment of vital organs.
- High risk factors for venous thromboembolism and abnormalities in coagulation mechanisms.
- Attending doctor considers inappropriate to take part in.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.