This trial aims to determine how effective stem cell therapy is for ovarian function among women with premature ovarian failure. The main outcome to be investigated is pregnancy rate and restart of menstruation. The trial is recruiting in Augusta (Georgia), United States
Premature ovarian failure is a loss of normal function of the ovaries in women less than 40 years old. This causes absent periods and abnormal hormone levels. The cause of premature ovarian failure is unclear. Currently, there is no treatment that is effective in restoring fertility in women with premature ovarian failure. Stem cell therapy uses immature cells that have not yet transformed into specialized cells. Initial studies suggest that stem cell therapy could be used to revive prematurely failed ovaries. This study will examine its benefit among women with premature ovarian failure.
Who are they looking for?
This study will recruit about 33 women with premature ovarian failure. Women should have had absent periods for at least 3 to 6 months and should be willing to attempt to become pregnant. There should be no other cause of infertility. Participants should have normal thyroid and prolactin levels. Male partners should not be infertile.
Participants should not be currently pregnant nor breastfeeding. They should not have any gynaecological cancer. Participants should not have diabetes, significant anaemia and not be receiving oral contraceptives, corticosteroids or anticoagulants within the past 3 months of the study. Participants should not have any current substance abuse.
How will it work
All participants will undergo a medical examination to confirm a diagnosis of premature ovarian failure at the start of the study. Part of the bone marrow will be taken to extract stem cells. This will be done under general anaesthesia. Laparoscopy (keyhole surgery) will be done to take a sample of the right ovary for analysis. Laparoscopy will then be performed to inject the stem cells into the right ovary.
Women will be monitored with pregnancy tests over 12 months. They will monitor themselves for the return of menstruation. Hormone levels such as follicle-stimulating hormone and progesterone will be measured over 12 months.