Reproductive Techniques, Assisted Clinical Trial
Official title:
A Phase III, Multicentric, Randomized, Open, Comparative Study to Evaluate if the Addition of Recombinant Human Luteinising Hormone [r-hLH (Luveris®)] to Follicle Stimulating Hormone (FSH) From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing Assisted Reproduction Technology (ART), Who Required High FSH Dose in a Previous Cycle
The present study was designed to investigate, in hyporesponder subjects, that required in a previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH) >3500 International Unit (IU), the possibility to decrease through recombinant human luteinizing hormone (r-hLH) supplementation, the FSH amount per oocytes retrieved and in the mean time to improve the overall cycle outcome.
Recombinant human follicle stimulating hormone (r-hFSH), which totally lacks LH activity, is
widely used to induce multiple follicle development in women under pituitary
desensitization, in order to submit them to treatment with assisted reproduction techniques
(ART). Clinical experience from hypogonadotropic-hypogonadic women suggests that while FSH
alone is sufficient to induce follicle development, LH plays a significant part in final
follicle maturation, estrogen synthesis and optimal endometrium growth.
This was a phase III, multicentre, randomized, open-label comparative study to evaluate if
the addition of r-hLH (Luveris) in a 2:1 ratio to FSH from day 8 of ovarian stimulation is
able to decrease the total FSH dose and to improve cycle outcome in 250 infertile women
undergoing ART, who required high FSH dose in a previous cycle (≥ 3500 IU). Subjects who
have met all the inclusion criteria, achieved pituitary desensitization and started
controlled ovarian hyperstimulation (COH) treatment with FSH, on stimulation day 8 (S8)
received an identification number and will be allocated to one of the two following arms:
Arm : FSH + r-hLH (2:1 ratio of FSH:r-hLH), Arm : FSH alone. Treatment with Luveris was
commenced on day 8 (S8) and continued until injection of hCG or cancellation of the
treatment cycle.
Monitoring of stimulation, FSH dose escalation, criteria for injection of hCG, ovum pick up,
embryo transfer and pregnancy confirmation took place according to standard management
practice. The in-vitro fertilization (IVF) or intracytosolic sperm injection (ICSI)
procedure, including luteal phase support, was performed according to each centres' normal
procedures.
The subjects were followed up and the treatment outcome (menstruation or pregnancy) was
recorded. The delivery outcome for any pregnant subjects was recorded in the Case Report
Form (CRF).
Information on the delivery outcome for each pregnancy was collected. Information on adverse
events was collected during the study period.
OBJECTIVES
The primary objective of the study was:
To determine whether the addition of r-hLH (Luveris) from day 8 of ovarian stimulation
reduces the FSH dose needed to obtain/retrieve each oocyte.
The secondary objectives of the study were:
- To determine whether the addition of Luveris to FSH at day 8 of ovarian stimulation
improves cycle outcome based on secondary endpoints
- To determine the safety of Luveris in this indication
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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