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patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins

patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins

letrozole + gonadotropins

patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins

GnRHa + gonadotropins

zhang changjun, doctor

The purpose of this study is to determine whether letrozole combined with gonadotropins are effective in the ovarian hyperstimulating for IVF/ICSI in patients with PCOS.

Polycystic ovarian syndrome (PCOS) occurs in 4% to 7% of all women of reproductive age and 20% of women presenting with anovulatory infertility. A significant proportion of these women will ultimately need assisted reproductive techniques. Various protocols of ovarian stimulation such as step up protocol, coasting, GnRH antagonists et al have been proposed for optimizing IVF results in patients with PCOS. The results of these studies have shown it not to be satisfied. The preliminary studies have proven that Letrozole, a potent and highly specific nonsteroidal aromatase inhibitor, could successfully induce ovulation in women with polycystic ovary syndrome. In spite of only a little study research of letrozole in IVF/ICSI cycle, for poor ovarian responders, addition of letrozole improved ovarian response to FSH and reduced gonadotrophin dose required for COH without having a negative impact on pregnancy rates. These reports prompted us to hypothesize that adjunctive use of letrozole in COH protocol for patients with PCOS would minimize the gonadotrophin dose, and consequently the cost, and lower the risk of OHSS in a IVF/ICSI treatment cycle.

Letrozole Combined With Gonadotropins (Gn) for Ovarian Stimulation Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) in Patients With Polycystic Ovary Syndrome (PCOS)

Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS

Yunyang Medical College

reproductive medicine research center

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Breast Diseases

Skin Diseases

ovarian stimulation after breast cancer diagnosis and before breast cancer treatment

No ovarian stimulation before breast cancer treatment

Letrozole 5 mg/day during ovarian stimulation

Ovarian stimulation in vitro fertilization cryopreservation

Kutluk H Oktay, MD, FACOG

Breast cancer patients are commonly treated with drugs that eggs present in the ovary and may reduce their chance for getting pregnant. Their fertility can be preserved by stimulating their ovaries, collecting multiple eggs, fertilize them in the lab and freeze them. Ovarian stimulation increase their estrogen levels in blood.this may stimulate their cancer and increase chance for recurrence. If a medicine that prevent estrogen rise is used (letrozole), this may increase the safety of stimulation. In this study we compared ovarian stimulation in breast cancer patients using letrozole with those who did not undergo stimulation and showed that there is no increase risk for recurrence after a median follow up of 2 years

215 women with breast cancer were evaluated for fertility preservation before chemotherapy. Of those, 79 elected to undergo controlled ovarian stimulation (COH) with letrozole and gonadotropins for embryo or oocyte cryopreservation. The 136 patients who declined served as controls.There were no significant differences between the study and control groups regarding age at diagnosis, breast cancer prognostic parameters (tumor size, grade, number of positive lymph nodes, estrogen receptor status, her2-neu overexpression and vascular space invasion), and chemotherapy regimens. There was no difference between the two groups in the projected 10 year relapse, breast cancer specific mortality or overall mortality. There were 3 recurrences or contralateral breast cancers (2 distant, 1 locoregional) in the letrozole group, and 11 in the control group (9 distant, 1 locoregional, 1 contralateral breast).

Comparison; breast cancer patients that underwent ovarian stimulation with letrozole+gonadotropins and those who declined ovarian stimulation.

Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients

Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients Undergoing Embryo or Oocyte Cryopreservation: A Prospective Controlled Follow up Study

New York Medical College

this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the French participating centres.

this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the Belgian participating centres.

this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and who have access to the Fertility Clinics in all the participating centres but are not willing to preserve their fertility by undergoing oocyte/embryo cryopreservation.

Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol.

"Standard Protocol": letrozole is orally administered (5mg/d) from cycle day 2-3 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering.

"Random start" protocol: letrozole is administered throughout the stimulation together with gonadotropins.

GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm.

Oocytes are collected 36h after ovulation triggering with GnRH agonist.

Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol.

"Standard Protocol": Gonadotrophins started from cycle day 2-3 throughout the ovarian stimulation until ovulation triggering.

"Random start" protocol: Gonadotrophins started at any time of the cycle and throughout the stimulation.

GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm.

Oocytes are collected 36h after ovulation triggering with GnRH agonist.

standard-stimulated cohort

Isabelle Demeestere, MD,PhD

Julie Dechene

Julie Dechène

Lydia Ait Ahcene

Oranite Goldrat, Md, PhD

Romain Imbert, MD

Chantal Schugens

Carine Garnier

Annick Delvigne, MD, PhD

Aline BARBERIO

audrey Mailliez, MD

Christine Decanter, MD

Matteo Lambertini, MD, PhD

Isabelle Demeestere, MD, PhD

This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.

Patients enrolled in this study undergo standard or "random start" ovarian stimulation with Gonadotropins using antagonist protocol before the beginning of chemotherapy. Ovulation is triggered in all patients with a Gonadotropin Releasing Hormone-GnRH agonist.

After retrieval, oocytes are denuded and matured oocytes are subjected to fertilization before embryo freezing or direct vitrification.

Primary objective is to evaluate the efficacy of performing a controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy in terms of mature oocytes collected.

3 groups:

* 113 patients in the standard-stimulated cohort,
* 113 patients in the letrozole-stimulated cohort,
* 339 patients in the non-stimulated cohort.

Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)

A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)

Adverse events reporting during COS (Ovarian Hyperstimulation syndrome-OHSS)

Total gonadotropin doses (International Unit- IU)

type of stimulation (standard or random-start).

Maturation rate (number of total oocyte collected/number of mature oocytes)

Number of pregnancies and outcomes (premature delivery, miscarriage, abortion, delivery healthy babies, congenital malformation).

Anti-Mullerian Hormone (AMH) measurements AMH ng/ml

Follicle-Stimulating Hormone (FSH) measurements FSH IU/L

Amenorrhea rate (6months without spontaneous menstruation)

Fertilization rate (number of oocyte fertilized/number of embryo obtained)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Letrozole Combined With Gonadotropins (Gn) for Ovarian Stimulation Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) in Patients With Polycystic Ovary Syndrome (PCOS)	NCT00894608	Polycystic Ovar...	letrozole + gon... GnRHa + gonadot...	-	Yunyang Medical College
Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients	NCT00504699	Breast Cancer	Ovarian stimula...	18 Years - 45 Years	New York Medical College
Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)	NCT04289805	Breast Neoplasm...	Letrozole standard-stimul...	18 Years - 40 Years	Erasme University Hospital
Letrozole Combined With Gonadotropins (Gn) for Ovarian Stimulation Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) in Patients With Polycystic Ovary Syndrome (PCOS)	NCT00894608	Polycystic Ovar...	letrozole + gon... GnRHa + gonadot...	-	Yunyang Medical College

Spots Global Cancer Trial Database for ovarian stimulation