Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer.
Status:
Recruiting
Trial end date:
2024-05-17
Target enrollment:
Participant gender:
Summary
1 in 7 couples experience difficulty in conceiving. Many will require in vitro fertilization
(IVF). IVF involves an initial period of downregulation to suppress the ovaries and prevent
premature ovulation. Hormone injections are then used to stimulate a woman's ovaries to
produce eggs which are removed by a minor operation. The harvested eggs are mixed with sperm
to create embryos in the laboratory. These embryos are replaced in the womb a few days after
they are created (fresh embryo transfer). Any remaining embryos are frozen such that they can
be thawed and transferred at a later date (frozen thawed embryo transfer, FTET).
The investigators have previously shown that the presence of moderate or severe adenomyosis
significantly reduces the chance of clinical pregnancy after embryo transfer. The purpose of
this study is to examine whether it is possible to improve the chance of clinical pregnancy
in these women by modifying the IVF protocol they undergo for FTET.
The hypothesis is that a prolonged downregulation regimen for women with adenomyosis would
reduce the inflammatory reaction in the endometrium of these women and thus improve the
chance of implantation after embryo transfer.
Consenting patients will be offered FTET. Those proceeding will be randomized to one of two
protocols (A - standard protocol vs. B - prolonged downregulation protocol). Women will also
be offered a questionnaire before and after IVF treatment to assess their adenomyosis
symptoms .
The primary outcome of the study is clinical pregnancy defined as an intrauterine pregnancy
with a visible heart beat older than 6 weeks gestation. Secondary outcomes include livebirth,
pregnancy loss (biochemical pregnancy, miscarriage, ectopic pregnancy, stillbirth,
termination of pregnancy), gestational age at delivery, birth weight, neonatal mortality,
major congenital anomaly, serious medication reaction, number of frozen embryos available for
transfer, number of days to achieve optimal endometrial thickness.