Recovery and processing of human embryos formed in vivo

Inventors

CARSON, Sandra Ann • Buster, John E.

Assignees

Butterfly Biosciences Inc

Abstract

Among other things, uterine lavage is performed to withdraw at least 50% of in vivo fertilized preimplantation embryos produced after superovulation of a woman and artificial insemination using sperm of her sexual partner. After genetic diagnosis or sex determination or gene therapy, or any combination of any two or more of them, of the recovered embryos and selection of at least one of the embryos to be implanted, the selected embryos are returned to the woman for implantation in her uterus.

Core Innovation

The disclosed invention concerns a process for recovering one or more blastocysts from a uterus of a human. The process uses superovulation to form multiple corpora lutea that undergo apoptosis and cannot support development of a viable implanted pregnancy. Fertilization is caused in vivo of multiple oocytes produced by the superovulation, and the fertilized oocytes are permitted to mature to form multiple mature preimplantation embryos that present to the uterus as blastocysts.

A device is placed trans-vaginally into a cervical canal of the human. Fluid is automatically delivered through the device to the uterus and a vacuum is automatically applied to aspirate fluid and entrained one or more blastocysts from the uterus without introducing air into the uterus. In parallel, the process causes desynchronization of the endometrium to reduce the chance that any embryos remaining in the uterus will form a viable pregnancy, wherein desynchronization comprises administering GnRH antagonist on the day on which the one or more blastocysts are recovered to induce further corpus luteum apoptosis, suppress luteal phase progesterone, and further decrease risk of a retained pregnancy.

In variants, impaired corpus luteum estradiol and progesterone production is supplemented to maintain embryonic viability and maturation. Superovulation is combined with blastocyst recovery using trans-vaginal placement, automatic fluid delivery while applying vacuum, and endometrial desynchronization on the recovery day using GnRH antagonist, with the aim of reducing retained pregnancy while enabling recovery of blastocysts for subsequent processing and outcome control.

Claims Coverage

The independent claims (clm-00001, clm-00039, clm-00050, clm-00051) each define a core process that combines in vivo formation of blastocysts, trans-vaginal fluid delivery with vacuum aspiration without introducing air, and endometrial desynchronization on the recovery day using GnRH antagonist; additional independence-to-independence differences include whether the claim specifies automatic delivery versus cyclic delivery and whether it includes estradiol/progesterone supplementation to maintain embryonic viability and maturation.

Across the independent claims, the main inventive coverage centers on enabling uterine blastocyst recovery by trans-vaginal fluid delivery and vacuum aspiration without introducing air, while concurrently controlling implantation outcomes by using superovulation to create corpora lutea that undergo apoptosis and by inducing endometrial desynchronization with GnRH antagonist on the blastocyst recovery day to reduce retained pregnancy risk. One independent claim variant further adds estradiol and progesterone supplementation to maintain embryonic viability and maturation.

Stated Advantages

Documented Applications

No documented applications found