Ovarian cortex transplantation: 60 reported live births brings the success and worldwide expansion of the technique towards routine clinical practice

Abstract This paper describes the success and expansion of ovarian tissue cryopreservation and transplantation as a fertility restoration procedure, with the largest series of 60 live births worldwide reported. By repeating the procedure, ovarian activity can be restored for more than 11 years

Linzagolix therapy versus a placebo in patients with endometriosis-associated pain: a prospective, randomized, double-blind, Phase 3 study (EDELWEISS 3)

Does linzagolix administered orally once daily for up to 3 months at a dose of 75 mg alone or 200 mg in combination with add-back therapy (ABT) (1.0 mg estradiol; 0.5 mg norethindrone acetate, also known as norethisterone acetate [NETA]) demonstrate better efficacy than placebo in the management of endometriosis-related dysmenorrhea and non-menstrual pelvic pain? Combining 200 mg linzagolix with ABT was found to significantly reduce dysmenorrhea and non-menstrual pelvic pain at 3 months of therapy, while a daily dose of 75 mg linzagolix yielded a significant decrease only in dysmenorrhea at 3 months. A previously published Phase 2, dose-finding study reported that at a dose of 200 mg daily, linzagolix promotes full suppression of estradiol secretion to serum levels below 20 pg/ml and noted that the addition of ABT may be needed to manage hypoestrogenic side effects. At lower doses (75 mg and 100 mg/day), linzagolix maintains estradiol values within the target range of 20-60 pg/ml, which could be ideal to alleviate symptoms linked to endometriosis. EDELWEISS 3 was a multicenter, prospective, randomized, placebo-controlled, double-blind, double-dummy Phase 3 study to evaluate the safety and efficacy of linzagolix for the treatment of moderate-to-severe endometriosis-associated pain. Treatment was administered orally once daily for up to 6 months. In the EDELWEISS 3 trial, 486 subjects with moderate-to-severe endometriosis-associated pain were randomized at a 1:1:1 ratio to one of the three study groups: placebo, 75 mg linzagolix alone or 200 mg linzagolix in association with ABT. Pain was measured daily on a verbal rating scale and recorded in an electronic diary. At 3 months, the daily 200 mg linzagolix dose with ABT met the primary efficacy objective, showing clinically meaningful and statistically significant reductions in dysmenorrhea and non-menstrual pelvic pain, with stable or decreased use of analgesics. The proportion of responders for dysmenorrhea in the 200 mg linzagolix with ABT group was 72.9% compared with 23.5% in the placebo group (P < 0.001), while the rates of responders for non-menstrual pelvic pain were 47.3% and 30.9% (P = 0.007), respectively. The 75 mg linzagolix daily dose demonstrated a clinically meaningful and statistically significant reduction in dysmenorrhea versus placebo at 3 months. The proportion of responders for dysmenorrhea in the 75 mg linzagolix group was 44.0% compared with 23.5% in the placebo group (P < 0.001). Although the 75 mg dose showed a trend toward reduction in non-menstrual pelvic pain at 3 months relative to the placebo, it was not statistically significant (P = 0.279). Significant improvements in dyschezia and overall pelvic pain were observed in both linzagolix groups when compared to placebo. Small improvements in dyspareunia scores were observed in both linzagolix groups but they were not significant. In both groups, hypoestrogenic effects were mild, with low rates of hot flushes and bone density loss of <1%. A daily dose of 200 mg linzagolix with ABT or 75 mg linzagolix alone was found to significantly reduce dysmenorrhea and non-menstrual pelvic pain also at 6 months of therapy. Efficacy was compared between linzagolix groups and placebo; however, it would be useful to have results from comparative studies with estro-progestogens or progestogens. It will be important to ascertain whether gonadotropin-releasing hormone antagonists have significant benefits over traditional first-line medications. Linzagolix administered orally once daily at a dose of 200 mg in combination with add-back therapy (ABT) demonstrated better efficacy and safety than placebo in the management of moderate-to-severe endometriosis-associated pain. The quality of life was improved and the risks of bone loss and vasomotor symptoms were minimized due to the ABT. The 75 mg dose alone could be suitable for chronic treatment of endometriosis-associated pain without the need for concomitant hormonal ABT, but further research is needed to confirm this. If confirmed, it would offer a viable option for women who do not want to wish to have ABT or for whom it is contraindicated. Funding for the EDELWEISS 3 study was provided by ObsEva (Geneva, Switzerland). Analysis of data and manuscript writing were partially supported by ObsEva (Geneva, Switzerland), Theramex (London, UK) and Kissei (Japan) and grant 5/4/150/5 was awarded to M.-M.D. by FNRS. J.D. was a member of the scientific advisory board of ObsEva until August 2022, a member of the scientific advisory board of PregLem, and received personal fees from Gedeon Richter, ObsEva and Theramex. J.D. received consulting fees, speakers' fees, and travel support from Gedeon Richter, Obseva and Theramex, which was paid to their institution. C.B. has received fees from Theramex, Gedeon Richter, and Myovant, and travel support from Gedeon Richter-all funds went to the University of Oxford. He was a member of the data monitoring board supervising the current study, and served at an advisory board for endometriosis studies of Myovant. H.T. has received grants from Abbvie and was past president of ASRM. F.C.H. has received fees from Gedeon Richter and Theramex. O.D. received fees for lectures from Gedeon Richter and ObsEva and research grants for clinical studies from Preglem and ObsEva independent from the current study. A.H. has received grants from NIHR, UKRI, CSO, Wellbeing of Women, and Roche Diagnostics; he has received fees from Theramex. A.H.'s institution has received honoraria for consultancy from Roche Diagnostics, Gesynta, and Joii. M.P. has nothing to declare. F.P. has received fees from Theramex. S.P.R. has been a member of the scientific advisory board of Gedeon Richter and received fees from Gedeon Richter. A.P. and M.B. are employees of Theramex. E.B. was an employee of ObsEva, sponsor chair of the data monitoring board supervising the current study, and has been working as a consultant for Theramex since December 2022; she owns stock options in ObsEva. M.-M.D. has received fees and travel support from Gedeon Richter and Theramex. NCT03992846. 20 June 2019. 13 June 2019

Recommendations for fertility preservation in patients with lymphoma, leukemia, and breast cancer

Fertility issues should be addressed to all patients in reproductive age before cancer treatment. In men, cryopreservation of sperm should be offered to all cancer patients in reproductive age regardless of the risk of gonadal failure. In women, the recommendation of fertility preservation should be individualized based on multiple factors such as the urgency of treatment, the age of the patient, the marital status, the regimen and dosage of cancer treatment

Réintroduction de cellules malignes après greffe de tissu ovarien

La réimplantation du tissu ovarien congelé permet de restaurer la fonction ovarienne et la fertilité. Si cette technique offre beaucoup d'espoir aux patientes qui ont bénéficié d'une chimiothérapie suffisamment agressive que pour causer une perte irréversible de la réserve ovarienne en follicules primordiaux, peu de papiers rapportent par ailleurs le risque de provoquer une récidive de la maladie en réintroduisant, via le tissu ovarien réimplanté, des cellules malignes. Le but de ce chapitre est d'évaluer le risque dans les différentes pathologies

FFER 28ème Journées de la Fédération Fançaise d'Etude de la Reproduction

Les 28èmes Journées de la FFER auront lieu en 2023 au Palais des congrès d’Arcachon en Nouvelle Aquitaine. Nous avons voulu souligner le caractère uni de la nouvelle région, puisque nous avons regroupé les efforts des principaux représentants impliqués dans l’AMP en Nouvelle Aquitaine : Bordeaux, Limoges et Poitiers. Cette année, nous avons choisi comme thème Echecs d'implantation et adjuvants qui restera le fil conducteur des ateliers et des sessions plénières sans oublier bien sûr les grandes thématiques médicales. Ces journées annuelles restent centrales pour les rencontres et les échanges entre les centres, les biologistes, les cliniciens, les laboratoires pharmaceutiques et les industriels impliqués dans la reproduction humaine. Cette collaboration, qui a toujours été fructueuse, nous semble une nécessité et une source de progrès

8th World Congress of International Society for Fertility Preservation (ISFP)

“Fertility preservation: the recent changes and expectations” “Ovarian tissue freezing to delay menopause”

Trials and tribulations of in vitro fertilization after ovarian tissue transplantation.

In their systematic review of ovarian stimulation and assisted reproductive technology (ART) outcomes in women who have undergone ovarian tissue transplantation (OTT) (1), Andersen et al. attempt to provide a consistent overview of the current state of play, which is no easy task given the heterogeneous and often discrepant data available on the subject. Indeed, questions raised in this article concerning issues of oocyte quality, poor ovarian reserve, empty follicle syndrome, and unfavorable in vitro fertilization (IVF) outcomes have not significantly changed since we first sought to address them more than 10 years ago, when we evaluated the quality of oocytes and embryos derived from frozen-thawed transplanted ovarian tissue in a series of women who had not conceived after 12 months of spontaneous cycles after OTT (2). In that study, the empty follicle rate per oocyte retrieval was 29% and the percentage of abnormal oocytes (immature or degenerated) was 38%. [...

Virtual IFFS World Congress

Freezing gonadal tissue after pubert