Subjects will receive the medication elagolix

Infertility

Endometriosis

Elagolix 200mg twice daily orally for 60 days prior to beginning frozen embryo transfer preparation

Elagolix 200 MG

Leuprolide Acetate intramuscularly every 28 days (twice) prior to beginning frozen embryo transfer preparation

Leuprolide Acetate 3.75 MG/ML

Serum follicle stimulating hormone (FSH), estradiol, luteinizing hormone (LH), progesterone, human chorionic gonadotropin (hCG), serum for microarray analysis, complete blood count, and chemistry panel with liver functions levels will be drawn via blood draw

Lab work

Colorado Center for Reproductive Medicine

Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

The Effect of Elagolix in Comparison to Leuprolide Acetate on in Vitro Fertilization (IVF) Cycle Outcomes After a Transfer of Euploid Embryos to Patients With Surgically Diagnosed Endometriosis: A Pilot Trial

Implantation rates of both groups will be compared (defined as number of intrauterine gestational sacs with visible cardiac activity noted on ultrasound examination performed 2-3 weeks after initial positive pregnancy test)

Comparative biochemical pregnancy rates (positive pregnancy tests with no evidence of intrauterine gestational sac noted at ultrasound performed 2-3 weeks after initial positive pregnancy test) per embryo transfer

FSH, LH, Estradiol, progesterone will compared after 4 weeks and 8 weeks of initiation of treatment

At the end of the pregnancy. Live birth rates and pregnancy loss rates will be compared between the two groups

Eric Surrey, M.D.

Medical Director

AbbVie

Test group will receive Elagolix 60 days prior to initiating frozen embryo transfer preparation.
Control group will receive depot leuprolide twice (once every 28 days) prior to initiation frozen embryo transfer preparation.

Deep Neuromuscular Block group Intervention: maintenance of a deep neuromuscular block by infusion of rocuronium at the starting dose of 0.3-0.6 mg / kg / h, titrated to maintain a TOF count of 0, and a PTC between 1-2.
Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point)

Moderate Neuromuscular Block group Intervention: maintenance of a moderate neuromuscular block. neuromuscular blockade will be maintained with intravenous bolus of rocuronium (0.15-0.25 mg/kg) titrated to obtain a TOF count of 1-3.
Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point)

Neuromuscular Blockade

evaluation of the intraoperative surgical conditions assessed by the surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point) given by deep vs moderate neuromuscular block

Quality of surgical field conditions

maintenance of a deep neuromuscular block by infusion of rocuronium

Deep Neuromuscular Block

maintenance of a moderate neuromuscular block.

Moderate Neuromuscular Block

University Federico II - AOU

Effects of Depth of Neuromuscular Block on Surgical Operating Conditions in Gynecologic Laparoscopic Surgery

Effects of Depth of Neuromuscular Block on Surgical Operating Conditions and on Time to Discharge From Post-anesthesia Care Unit in Patients Undergoing Gynecologic Laparoscopic Surgery: a Randomized Prospective Clinical Trial

impact of a deep neuromuscular blockade (TOF count = 0 and posttetanic count [PTC] 1-2) and a moderate neuromuscular blockade (TOF count= 1 - 3) on intraoperative surgical conditions assessed by the surgeon as a 5 points scale

the time to discharge from post-anesthesia care unit (PACU) assessed with the WAKE© score (WAKE Score "0-10". Criteria: Blood Pressure / Heart Rate 2 - 1 - 0 ; Movement 2 - 1 - 0; Mental Status 2 - 1 - 0; Respiratory 2 - 1 - 0; O2 Saturation 2 - 1 - 0)

individual participant data will be stored locally

Edoardo De Robertis

Associate Professor

Federico II University

After enrollment, patients will be randomized in the two study groups:
Deep Neuromuscular Block group (group DNMB) Moderate Neuromuscular Block group (group MNMB)

in the assessment of the surgical field quality surgeons are blind respect the level of neuromuscular block received by patients

A 2 to 4 weeks run-in period is planned, during which all patients receive single blinded "hot flash evaluation treatment" which is actually a placebo (2 tablets every morning and every evening during 2 to 4 weeks). At the end of this period, the hot flash score is calculated. If the score is ≥10, the patient can be randomized to one of the 2 arms:
Experimental: BRN01
Placebo Comparator: Placebo

Breast Cancer

2 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).

BRN01

Placebo

Centre Hospitalier de Chambery

Centre Jean Perrin

Centre Leon Berard

Centre Hospitalier de Montelimar

Centre Hospitalier d'Annecy

Centre Hospitalier de Roanne

Clinique Armoricaine de radiologie

Institut de Cancérologie Lucien Neuwirth

Centre Hospitalier de Valence

Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer

Placebo-controlled Evaluation of the Homeopathic Drug BRN01 for the Treatment of Hot Flashes in Women With Non Metastatic Breast Cancer Treated by Adjuvant Hormonal Therapy

The hot flash score is equal to: (number of hot flashes/day) x (mean intensity/day).
Treatment efficiency scores will be calculated as follows: (hot flash score on the 4th week of the second period)-(hot flash score on the 2nd week of the first period).
Then efficiency scores will be compared between the 2 arms (placebo versus BRN01).

Treatment efficacy scores will be calculated as follows: (hot flash score on the 8th week of the second period)-(hot flash score on the 2nd week of the first period).
Then efficiency scores will be compared between the 2 arms (placebo versus BRN01).

BOIRON

This group of patients will receive estradiol patches prior to the IVF cycle.

This group of patients will receive OCP's prior to the IVF cycle.

IVF Poor Responders

Estradiol

Oral Contraceptive Pills (OCP)

Duke Fertility Center

Optimizing Ovulation Induction in the Poor Responder

Optimizing Ovulation Induction in the Poor Responder: a Randomized Clinical Trial of Luteal Phase Estradiol Versus Combined Oral Contraceptive Pill on Ovarian Morphology and Biomarkers Prior to Ovulation Induction

We will measure follicular response and synchrony following adminstration of extradiol patches or oral contraceptive pills.

ovarian cysts/illamående

Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

Effects of Depth of Neuromuscular Block on Surgical Operating Conditions in Gynecologic Laparoscopic Surgery

Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer

Optimizing Ovulation Induction in the Poor Responder

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