Press release July 16, 2024

FSH-free versus FSH-primed infertility treatment of women with polycystic ovary syndrome using biphasic in vitro maturation: a randomized clinical trial

AMSTERDAM, July 10, 2024

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 40 Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) on July 9, 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:

Prof. Dr. Andre Rosenthal
andre.rosenthal@lavimafertility.com

Prof. Dr. Johan Smitz
johan.smitz@lavimafertility.com 

Press release July 03, 2024

IVI RMA Global and Lavima Fertility join forces in research in fertility treatments

VALENCIA and Brussels, July 3, 2024

Seeking alternatives to obtain oocytes without ovarian stimulation is a pioneering line of research in reproductive medicine. The inconveniences that the process of ovarian stimulation can generate are a current barrier for some women and couples who are considering starting a reproductive treatment. In fact, 1 out of every 5 couples do not start the search for a second child for this reason.

Ovarian stimulation is the initial part of assisted reproduction treatments, and it is the phase of infertility treatments in which the least relevant advances have been achieved to date. It is one of the main psychological barriers for women when deciding to begin this path towards motherhood. Many of them are concerned about how this process may affect them physically and emotionally.

With the aim of making progress in this field, IVI RMA GLOBAL has signed an exclusive agreement with Lavima Fertility, Inc., a US company in the fertility sector which owns the rights to CAPA-IVM – a completely novel hormone-free fertility treatment technology. Together, IVI RMA Global and Lavima Fertility have opened a pioneering line of research aimed at eliminating ovarian stimulation in women who wish to begin assisted reproduction or egg vitrification treatment.

“We are aware that the ovarian stimulation phase can be faced with some anxiety and can be a brake on the decision to begin treatment. For this reason, at IVI and together with Lavima Fertility, we have taken the initiative and we are going to challenge science to try to optimize this very delicate part of the treatment for some patients”, explains Dr. Nuria Pellicer, gynecologist at IVI Valencia.

A clinical study has begun at the IVI Valencia headquarters under the direction of Dr. Ernesto Bosch, director of the clinic, and Dr. Nuria Pellicer, together with the scientific director of IVI RMA Global, Dr. Juan Antonio García Velasco. Lavima Fertility is supporting this clinical study by providing the CAPA-IVM and culture media supplements that allow immature oocytes to mature outside of the women’s ovaries in vitro and without the need of ovarian stimulation. This investigation will later be joined by the rest of the IVI RMA Global group’s clinics.

“Our main objective is to continue benefiting women through research, and to eliminate the psychological barrier of those who decide not to start treatment, worried about the physical and emotional effect that ovarian stimulation may have on them, although the symptoms associated with this process are usually moderate and pass in a few days,” says Dr. Bosch.

In spite of being a fundamental step in the treatment of fertility, it is estimated that 20% of couples who would like to look for a second child do not do so due to their reluctance regarding the possible effects of ovarian stimulation: “Finding formulas to improve this process from science is an exciting and hopeful project for us, in our continuous research work, and allows us to continue helping in a pioneering way and with the latest advances to women who trust us with their greatest desire”, concludes Dr. Pellicer.

“Avoiding controlled ovarian stimulation together with the trigger hormones in ART represents clearly a great scientific and clinical innovation”, says Prof. Dr. Johan Smitz from Lavima Fertility. Immature eggs are retrieved from unstimulated small follicles. The oocyte-cumulus-complexes are then matured in a novel two-step process in vitro using several culture media supplements. This technology is called CAPA-IVM. Five randomized clinical studies have been conducted in Asia and over 850 babies have been born already using this novel hormone free fertility treatment technology, underlying the safety of CAPA-IVM.

“We are excited about the research collaboration between IVI RMA Global and Lavima Fertility in the field of hormone-free fertility treatment. IVI RMA Global is the largest IVF chain in the world and working together with IVI RMA Global clinics in this field would allow to bring CAPA-IVM to many more patients worldwide in the future”, concludes Prof. Smitz.”

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About IVI

IVI was founded in 1990 as the first medical institution in Spain to specialize entirely in Human Reproduction. Since then, it has helped more than 250,000 children to be born thanks to constant innovation and the development of the most innovative assisted reproduction treatments.

It is one of the European centers with the best pregnancy rates; in fact, most couples who consult IVI for infertility problems achieve their goal. In addition, it has a team of more than 2,500 professionals, including the best gynecologists in the world.

IVI is part of the IVI RMA Global group, present in 15 countries. In addition to Spain, it is present in Portugal, Italy, the Czech Republic, the Nordic countries, United Kingdom, USA, Canada, Panama, Brazil and Chile.

https://ivirma.com

For more information:

Lucía Renau lucia.renau@ivirma.com
Ricardo Pedrós ricardo.pedros@ivirma.com

APPLE TREE
Anaïs Priego ap@appletree.agency
Clara Martínez cla@appletree.agency

About Lavima Fertility,  Inc.

Lavima Fertility was founded in 2020 as a spin-off from the Free University of Brussels (VUB). Lavima owns the wordwide exclusive license to the CAPA-IVM technology which was originally developed at Free University of Brussels by Prof. Johan Smitz and co-workers. The CAPA-IVM technology is a novel, completely hormone free fertility treatment technology. Several thousands of patients have been treated with CAPA-IVM in Asian countries and Australia. More than 850 babies have been born after CAPA-IVM cycles. The CAPA-IVM technology is protected by granted patents in major territories. Lavima Fertility is cooperating with leading IVF clinics to evaluate the CAPA-IVM technology for various patient cohorts with the aim to further optimize the technology and complete the clinical development of the CAPA-IVM System Kit.

www.lavimafertility.com

For more information:

Prof. Dr. Andre Rosenthal
andre.rosenthal@lavimafertility.com

Prof. Dr. Johan Smitz
johan.smitz@lavimafertility.com 

Press release 06/07/2022

Long-term Infant Data Provides Reassurance on Novel Capacitation – In vitro Maturation (CAPA-IVM) Fertility Method

July, 6th, 2022 – A new 2-year infant follow-up study reported no difference in developmental outcomes in children born after capacitation-in vitro maturation (CAPA-IVM) compared to those born through conventional in vitro fertilization (IVF) following ovarian stimulation. The study was designed to detect developmental delay in children in terms of communication, gross motor, fine motor, problem solving and personal–social behavior. It included a total of 231 children who were evaluated at 6 months, 12 months and 24 months after birth.

The study results were presented by Prof. Dr. Tuong M Ho at the 38th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) on July 6th, 2022 in Milano (Italy) and have been published in Human Reproduction1, a leading reproductive medicine journal.

Prof. Dr. Lan Vuong from MyDuc hospital, HCMC, Vietnam, who led the study, said: “One of the key messages of this study is that there does not appear to be any significant concern about the safety of CAPA-IVM on childhood development.” The current results complement recent findings that CAPA-IVM does not show any major epigenetic alterations or imprinting defects in in-vitro matured oocytes2. Dr. Vuong believes that continuing building evidence on CAPA-IVM is important to physicians considering alternative approaches to current 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 for the patient. The worldwide rights to the CAPA-IVM technology are owned by Lavima Fertilty, Inc.

References

1.  Vuong LN, Nguyen MHN, Nguyen NA, Ly TT, Tran VTT, Nguyen NT, Hoang HLT, Le XTH, Pham TD, Smitz JEJ, Mol BW, Norman RJ, Ho TM. Development of children born from IVM versus IVF: 2-year follow-up of a randomized controlled trial. Human Reproduction 2022, pp. 1–9, deac115

2.  Saenz-de-Juano MD, Ivanova E, Romero S, Lolicato F, Sánchez F, Van Ranst H, Krueger F, Segonds-Pichon A, De Vos M, Andrews S, Smitz J, Kelsey G, Anckaert E. DNA methylation and mRNA expression of imprinted genes in blastocysts derived from an improved in vitro maturation method for oocytes from small antral follicles in polycystic ovary syndrome patients. Human Reproduction 2019 Sep 29;34(9):1640-1649.

Contact

Prof. Andrè Rosenthal
andre.rosenthal@lavimafertility.com

Press release, March 9, 2022

VUB spin-off Lavima Fertility develops novel fertility treatment that reduces risks and burden

March, 9th, 2022 – Couples unable to get pregnant naturally often resort to In Vitro Fertilisation (IVF) to fulfil their desire to have children. To obtain mature eggs for IVF, women typically undergo ovarian stimulation with hormones which can be very burdensome. A team of scientists of the Follicle Biology (FOBI) Research Laboratory  at the Vrije Universiteit Brussel (VUB) in collaboration with the UZ Brussel fertility clinic has succeeded in developing a novel method for In Vitro Maturation (IVM) of oocytes, called CAPA-IVM. This is a method allowing a mild and low-burden fertility treatment for subfertile patients. To bring the technique to the patient, Lavima Fertility, a spin-off company of the VUB and UZ Brussel, was created.

The CAPA-IVM method is an alternative approach to obtaining eggs in women undergoing IVF, in which the egg cells of the woman are retrieved after minimal or even absent hormone treatment and then matured in vitro. The eggs are then fertilized and follow the standard embryo culture and transfer procedures as in standard IVF. The CAPA-IVM technology could become a more patient-friendly alternative to standard IVF as it reduces the exposure to hormones and avoids the associated hormonal side effects.

Initial clinical evidence of the efficacy and safety of the CAPA-IVM technology is very promising. A total of 96 babies were born by CAPA-IVM as a result of the published randomized study comparing CAPA-IVM to standard IVF1. The neonatal health of the babies born from either IVF approach was similar.1

CAPA-IVM can also be applied in the field of oncofertility which aims at preserving oocytes in female cancer patients.

“The main advantage of CAPA-IVM is that it reduces risks and burden for people who wish to become parents. We also enable new options for cancer patients.”

Em. Prof. Dr. Johan Smitz, VUB

“We are proud that research from UZ Brussel can now be further harnessed to help even more patients through the creation of Lavima Fertility. This opens up perspectives for many cancer patients and women with PCOS.”

Prof. Dr. Marc Noppen, CEO UZ Brussel

References

1. Vuong L, et al.:  In vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial. Hum Reprod.  2020,35: 2537-2547.


Contact

Prof. Dr. Andre Rosenthal
andre.rosenthal@lavimafertility.com

Prof. Dr. Johan Smitz
johan.smitz@lavimafertility.com 

About Lavima Fertility,  Inc.

Lavima, a US stock corporation, was founded in 2020 by em. Prof. Dr. Johan Smitz (VUB), Prof. Dr. Andre Rosenthal (ex Roche Diagnostics, US) and Elien van Hecke (ex Roche Diagnostics, Belgium) based on the work carried out over the past ten years at VUB and UZ Brussel. In September 2020, Lavima obtained an exclusive license to the CAPA technology from VUB. In 2021, Dr. Joan-Carles Arce (ex Ferring Pharmaceuticals) joined the founder team. Lavima is pursuing the future development and commercialization of the CAPA technology.

www.lavimafertility.com

About FOBI

The Follicle Biology Laboratory of the VUB carries out research in the field of oocyte biology including the design and validation of new culture systems for ovarian follicles and unripe egg cells to establish practical, applicable strategies for fertility clinics.

https://researchportal.vub.be/en/organisations/follicle-biology

About Brussels IVF

Brussels IVF (former CRG), the fertility clinic of UZ Brussel, specialises in fertility treatments (ART). We have an international reputation as pioneers in the development of ART-techniques and their application. Since the creation in 1983, more than 40.000 babies have been born following fertility treatment of the parents.

As a university institution within the VUB network, Brussels IVF also has an academic mission: our centre is also a training institute and acts as an engine for scientific research. 

www.brusselsivf.be

About VUB

Vrije Universiteit Brussel is an internationally oriented university in Brussels, the heart of Europe. By providing excellent research and education on a human scale, VUB wants to make an active and committed contribution to a better society.

www.vub.be

About UZ Brussel

UZ Brussel (University Hospital Brussels) has a staff of more than 3,800 employees. It is attached to the Faculty of Medicine and Pharmacy of the Vrije Universiteit Brussel (Free University of Brussels) on the Brussels Health Campus in Jette. With 721 hospital beds, it accounts for 30,779 admissions of patients each year from Belgium and abroad, 412,246 consultations (emergencies not included) and 78,840 patients at the emergency care. Its philosophy is founded on three principles: Dutch-speaking, pluralist and social. As a university hospital, it also has a teaching mission and conducts scientific research.

www.uzbrussel.be

About VUB Vice-Rectorate Innovation & Industry Relations

The mission of the Vice-Rectorate Innovation & Industry Relations is to create a positive impact on society through the valorization of scientific research. Its operational and multidisciplinary team, VUB TechTransfer, aims to connect the university’s research expertise with society-industry, together with its partners VUB Foundation and Crosstalks.

www.vub.be/en/innovate