Researchers at Keio University are planning a clinical study of a womb transplant to enable women without a uterus to fall pregnant and give birth, which would be a first in Japan.

The team, led by Iori Kisu, a project assistant professor at the university, submitted the draft plan to the Japan Society of Obstetrics and Gynecology on Nov. 7.

Uterus transplantation has been performed overseas for women without a uterus--a disorder known as Rokitansky syndrome--and for women who have had a hysterectomy due to cancer.

At least 54 cases of uterus transplant operations have been reported around the world, including the United States and countries in Europe, resulting in 13 births to date.

In Japan, an estimated 50,000 to 60,000 women in their 20s and 30s are without a uterus due to Rokitansky syndrome or hysterectomy.

The Keio University team’s step toward the uterus transplantation could be a blessing to many women trying to fall pregnant.

But various hurdles will need to be cleared before the team can go ahead with the transplantation.

One issue concerns ethics. In Japan, organ transplantation, for example, of the heart, kidney and liver were performed as a last-ditch effort to save a patient's life.

The team may have to present a strong argument for organ transplantation for reproductive purposes as the recipient’s life is not in danger.

Uterus transplantation can be risky for a donor because hysterectomy can often take a long time and involve excessive bleeding.

There also are concerns about the impact on a fetus through the use of an immunosuppressive drug by the recipient, which will be administered if her body tries to reject the transplanted uterus.

The Japan Society of Obstetrics and Gynecology, together with the Japan Society for Transplantation, will begin setting out the conditions under which the uterus transplant will be performed safely.

The university team plans to perform transplantation on five women after receiving uteruses from their mothers or siblings.

After the transplantation, the women will be prescribed with immunosuppressive drug to rein in the rejection response.

After giving birth, the women will have the donated uterus removed because the continued use of immune-suppressing drug is harmful to health.

It is expected to take at least two years from uterus transplantation to giving birth, if there are no hitches.

In general, researchers are required to submit a plan for a clinical study to the ethical committee of a medical institution where they work so that it can be examined before they proceed.

But since there are no set rules on uterus transplantation in Japan, Keio University’s ethical committee is not equipped with guidelines for scrutinizing the planned project.

As a result, the team decided to submit its plan to the Japan Society of Obstetrics and Gynecology first for scrutiny and proposal for points that need to be further explored to ensure the project’s safety before the ethical committee’s eventual examination.