An Exploratory Trial to Assess the Efficacy and Safety of Luveris in Women at Risk of Poor Response Undergoing Controlled Ovarian Stimulation (COS) Prior to Intracytoplasmic Sperm Injection (ICSI) With Gonal-f and Cetrotide

2014-08-27 03:14:06 | BioPortfolio


This was a prospective, randomised, comparative with parallel control, Phase 2 exploratory trial to assess the efficacy and safety of mid follicular Luveris in 60 women at risk of poor response undergoing COS prior to ICSI with Gonal-f and Cetrotide.


Large protocols have been dedicated to overcome the problem of poor ovarian response and encouraging results have obtained. This proposal was to complement COS with follitropin alfa by adding lutropin alfa at the time of gonadotropin releasing hormone (GnRH) antagonist administration to prevent endogenous luteinising hormone (LH) surge. The reasons were:

- Recombinant-follicle stimulating hormone (r-FSH) will promote follicular growth and by aromatase activation will stimulate estradiol (E2)synthesis.

- Recombinant-human LH (r-hLH) besides acting on theca cells to provide androgens to be converted to E2, will finalize the maturation of granulosa cells from developed follicles and, at the same time, will produce atresia of less developed follicles lacking of mature granulosa cells.

- The use of GnRH antagonist strongly suppresses serum LH levels thus the exogenous administration of lutropin alfa.


- To assess the efficacy of the simultaneous addition GnRH antagonist and r-hLH versus no addition of r-hLH, in subjects at risk of poor response aged < 38 years undergoing COS with r-hFSH prior to ICSI, in terms of oocyte number and quality as well as follicular development, oocyte fertilisation, embryo quality and pregnancy rates

- To assess the safety of using r-hLH in combination with r-hFSH in a protocol of COS with GnRH antagonist, including incidence of ovarian hyperstimulation syndrome (OHSS) and adverse events (AEs) as well as local tolerance.

The study was organised on an outpatient basis. All subjects underwent COS according to centre´s standard protocol (but Luveris) when a GnRH antagonist was going to be used. The COS was started on day 2-3 of the cycle with an initial dose of follitropin alfa ranging from 225 to 450 IU/day depending on subjects' baseline profile. Then the daily dose was adjusted according to ovarian response. When detected a follicle ≥ 14 mm or serum E2 levels > 200 pg/ml, then both 0.25 mg/day of Cetrotide and 150 IU/day of Luveris were initiated. Randomisation to Luveris supplementation or not took place at any time between the fourth day of COS (S4) and the first dose of Cetrotide, which were administered in the morning. Once COS completed, follitropin alfa, lutropin alfa, and Cetrorelix were stopped and recombinant-human choriogonadotropin (r-hCG) administered within the following 24 hours. Standard criteria for r-hCG administration were the presence of at least of one follicle ≥18 mm and two addition follicles > 16 mm together with appropriate E2 levels for the follicular number and size.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Controlled Ovarian Stimulation


Follitropin alpha (r-FSH) and Lutropin alfa (r-hLH), Follitropin alpha (r-FSH)


Hospital Universitario de La Fe




Merck KGaA

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:06-0400

Clinical Trials [2707 Associated Clinical Trials listed on BioPortfolio]

Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders

In an opened randomized study of women undergoing in vitro fertilization with expected suboptimal response to controlled ovarian stimulation (Poseidon Group 2b) investigators will examine ...

Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age

In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will ...

To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen

This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with fo...

A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.

The purpose of this phase 2 dose-ranging trial is to investigate the effects of FE 999302 on parameters influencing pregnancy rates in women undergoing Controlled Ovarian Stimulation (COS)...

Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/IC...

PubMed Articles [7424 Associated PubMed Articles listed on BioPortfolio]

Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial.

This phase III, double-blind, randomised, placebo-controlled trial (and extension phase) was designed to assess the efficacy and safety of velmanase alfa (VA) in alpha-mannosidosis (AM) patients.

Role of Alpha-Smooth Muscle Actin and Fibroblast Activation Protein Alpha in Ovarian Neoplasms.

Studies show that tumor growth is not just determined by the presence of malignant cells, since interactions between cancer cells and stromal microenvironment have important impacts on the cancer grow...

Basophil Activation Test Differentiates Between Patients with Alpha-Gal Syndrome and Asymptomatic Alpha-Gal Sensitization.

The alpha-gal syndrome is characterized by the presence of sIgE antibodies to alpha-gal and delayed type I allergic reaction to the carbohydrate galactose-alpha-1,3-galactose (alpha-gal) after consump...

Detection of alpha radionuclides in air from patients during Ra-223 alpha radionuclide therapy.

Ra-223 has recently been introduced to alpha radionuclide therapy. According to the decay scheme of Ra-223, an inert gas, Rn-219 is released from patients during alpha radionuclide therapy and its dau...

Longterm Homecare Augmentation Program in Alpha-1-Antitrypsin Deficient Patients.

Augmentation with human alpha-1 proteinase inhibitor is the only specific treatment for Alpha-1-Antitrypsin Deficiency (AATD), a rare genetic disease with symptoms of progressive COPD.

Medical and Biotech [MESH] Definitions

(9 alpha,11 alpha,13E,15S)-9,11,15-Trihydroxyprost-13-en-1-oic acid (PGF(1 alpha)); (5Z,9 alpha,11,alpha,13E,15S)-9,11,15-trihydroxyprosta-5,13-dien-1-oic acid (PGF(2 alpha)); (5Z,9 alpha,11 alpha,13E,15S,17Z)-9,11,15-trihydroxyprosta-5,13,17-trien-1-oic acid (PGF(3 alpha)). A family of prostaglandins that includes three of the six naturally occurring prostaglandins. All naturally occurring PGF have an alpha configuration at the 9-carbon position. They stimulate uterine and bronchial smooth muscle and are often used as oxytocics.

1,4-alpha-D-Glucan-1,4-alpha-D-glucan 4-alpha-D-glucosyltransferase/dextrin 6 alpha-D-glucanohydrolase. An enzyme system having both 4-alpha-glucanotransferase (EC and amylo-1,6-glucosidase (EC activities. As a transferase it transfers a segment of a 1,4-alpha-D-glucan to a new 4-position in an acceptor, which may be glucose or another 1,4-alpha-D-glucan. As a glucosidase it catalyzes the endohydrolysis of 1,6-alpha-D-glucoside linkages at points of branching in chains of 1,4-linked alpha-D-glucose residues. Amylo-1,6-glucosidase activity is deficient in glycogen storage disease type III.

Enzymes that catalyze the exohydrolysis of 1,4-alpha-glucosidic linkages with release of alpha-glucose. Deficiency of alpha-1,4-glucosidase may cause GLYCOGEN STORAGE DISEASE TYPE II.

A biologically active 5-alpha-reduced metabolite of plasma PROGESTERONE. It is the immediate precursor of 5-alpha-pregnan-3-alpha-ol-20-one (ALLOPREGNANOLONE), a neuroactive steroid that binds with GABA(A) RECEPTOR.

A biologically active 20-alpha-reduced metabolite of PROGESTERONE. It is converted from progesterone to 20-alpha-hydroxypregn-4-en-3-one by the 20-ALPHA-HYDROXYSTEROID DEHYDROGENASE in the CORPUS LUTEUM and the PLACENTA.

More From BioPortfolio on "An Exploratory Trial to Assess the Efficacy and Safety of Luveris in Women at Risk of Poor Response Undergoing Controlled Ovarian Stimulation (COS) Prior to Intracytoplasmic Sperm Injection (ICSI) With Gonal-f and Cetrotide"

Quick Search


Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Endocrine Disorders
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...

Diabetes Diabetes Endocrine Obesity Oxycontin Renal Disease Thyroid Disorders Endocrinology is the study of the endocrine glands and the hormones that they secrete (Oxford Medical Dictionary). There are several groups of h...

Searches Linking to this Trial