FSH-free versus FSH-primed infertility treatment of women with polycystic ovary syndrome using biphasic in vitro maturation: a randomized clinical trial
July 10 2024 - 9:37AM
This randomized, controlled trial was conducted at a tertiary IVF
center, Ho Chi Minh City, Vietnam. Between January 2023 and June
2023, 120 women were randomized. Eligible women were aged 18–37
years with polycystic ovarian syndrome (PCOS). After providing
written informed consent, participants were randomized (1:1) to
undergo CAPA-IVM with or without FSH-priming. Participants in the
FSH-priming group received two days of recombinant FSH (rFSH)
injections before oocyte pick-up; no rFSH was given in the non-FSH
group. All retrieved cumulus oocyte complexes underwent biphasic in
vitro maturation (CAPA-IVM). Matured oocytes underwent
fertilization through ICSI procedure, and were cultured to
blastocyst stage followed by vitrification. Participants underwent
a single blastocyst transfer during a frozen replacement cycle. The
primary endpoint was the number of matured oocytes.
The number of matured oocytes after CAPA-IVM did not differ
significantly between the non-FSH and FSH groups (13 [9; 18] vs. 14
[7; 18]; absolute difference –1 [95% confidence interval –5, 4]).
There were also no significant between-group differences in other
oocyte and embryology outcomes, including the number of
cumulus-oocyte complexes, number of fertilized oocytes, total
number of blastocysts and good blastocysts, and total number of
frozen embryos. The live birth rate was 38.3% in the non-FSH group
and 31.7% in the FSH group, with no statistically significant
difference. The miscarriage rate at <12 weeks’ gestation was
5.0% in both groups. Maternal complications were infrequent and
occurred at a similar rate in the non-FSH and FSH groups; there
were no preterm deliveries before 32 weeks’ gestation.
The study results were presented by Dr. Tuong M Ho at the 40th
Annual Meeting of the European Society of Human Reproduction and
Embryology (ESHRE) on July 9th, 2024 in Amsterdam (The Netherlands)
and have been submitted for publication in a leading
reproductive medicine journal.
Prof Dr Lan Vuong from The University of Medicine and Pharmacy
at Ho Chi Minh City and MyDuc hospital, HCMC, Vietnam, who led the
study, said: “This randomized controlled trial with 120 patients
proves that CAPA-IVM without rFSH priming is as effective as two
days of rFSH priming. With a live birth rate of 38% for single
blastocyst transfer CAPA-IVM achieved a similar live birth rate
than standard IVF with 8-10 days of rFSH treatment. This is great
news and a milestone achievement. The data supports our belief that
women with PCOS are suitable for a complete gonadotrophin free,
alternative fertility treatment.”
About CAPA-IVM
CAPA-IVM is a novel approach to in-vitro maturation of oocytes
recovered after no or minimal ovarian stimulation, that
incorporates a capacitation step in the maturation of oocytes in
vitro which enhances oocyte developmental competence. CAPA-IVM is a
patient-friendly assisted reproductive technology method that may
become an alternative option to conventional ovarian stimulation
and IVF, with reduced treatment burden in some selected groups of
patients. The worldwide rights to the CAPA-IVM technology are owned
by Lavima Fertility, Inc. Lavima Fertility is developing a medical
device for future application of this technology.
www.lavimafertility.com
For more information:André
Rosenthal andre.rosenthal@lavimafertility.comJohan
Smitz johan.smitz@lavimafertility.com