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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

Summary

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.

Description

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.

OBJECTIVES

- 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

Conditions

Controlled Ovarian Stimulation

Intervention

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

Location

Hospital Universitario de La Fe
Valencia
Spain

Status

Completed

Source

Merck KGaA

Results (where available)

View Results

Links

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

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