Infertility Clinical Trial
Official title:
Exploratory Study to Determine the Effect of Lutropin Alfa on Embryo Quality and Their Implantation in Women of Advanced Reproductive Age
This is a multicentric, open, randomized, comparative trial aimed to assess the influence of recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation (COS) in advanced reproductive age in terms of improved embryo competence which allows to transfer less embryos to avoid high grade multiple pregnancy without reducing the pregnancy rate.
This study will be carried out by the Grupo de Interés de Salud Embrionaria (GISE) group
(part of the Spanish Fertility Society) who uses strict criteria to select the embryos most
suitable for successful transference.
OBJECTIVES
Primary objective:
- To determine the benefit of r-LH supplementation in COS prior to in-vitro fertilization
(IVF)/intracytosolic sperm injection (ICSI) in advanced reproductive age, in terms of
embryo competence to implant, as compared against no r-LH supplementation
Secondary objectives:
To evaluate the benefit of r-LH supplementation in COS, in terms of:
- follicular development
- length of the stimulation
- oocyte number and their maturity
- fertilization rate
- embryo number and quality
- gestational sacs
- abortion
- ongoing pregnancies
- local and systemic safety of r-LH administration
The study will consist of 2 groups randomized in 1:1 ratio and each subject would be
followed up until the confirmation of her pregnancy status. Each subject will be
administered gonadotropin releasing hormone (GnRH) agonist subcutaneously daily from
previous mid luteal phase to r-hCG administration as a standard practice to achieve down
regulation. Each subject will also be administered recombinant follicle stimulating hormone
(r-FSH) at a starting dose of 300 IU from S1 up to ovarian stimulation completion (r-hCG
day) as a part of standard practice. In addition to the above concurrent therapies, one
group will be administered experimental treatment (Luveris®) and the other group (control
group) will not be administered any other drug (control treatment) during the stimulation
period from stimulation start (S1) up to ovarian stimulation completion or stimulation
cancellation respectively. Ovarian stimulation on an average takes 11 days and it is
expected that stimulation period will not be extended beyond 15 days. A single injection of
r-hCG will be administered intramuscularly or subcutaneously after the last injection of
Luveris or r-FSH to achieve final follicular maturation. After, 34-36 hours of
administration of r-hCG OPU will be done for oocyte retrieval and embryo transfer (ET) will
be conducted within 5 days from OPU. Subjects will also be provided luteal support with
natural progesterone and will be followed until delivery or miscarriage. Ultrasound and
estradiol (E2) assessment of follicular growth will be conducted at various time points
during the stimulation period with or without treatment adjustment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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