Track topics on Twitter Track topics that are important to you
This was a prospective, randomised, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the follicular phase in subjects undergoing in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of embryos (ET).
Few evidences suggest that aged subjects have more possibilities of obtaining a benefit from the combined use of FSH and LH. This study was designed to find out whether the addition of r-hLH on the sixth day of stimulation with r-hFSH in conventional protocol improves the assisted reproduction in terms of quality of recovered oocytes, implantation rates and pregnancy rates in subjects.
Delayed pregnancy and women of 35 years or more have important limitations regarding the success of IVF. It represents a real challenge for assisted reproduction due to the risk of achieving unsatisfactory follicular recruitment and growth, which would result in the controlled ovarian stimulation (COS). It is a common practice to start COS with high doses of FSH in aged subjects when gonadotropin releasing hormone (GnRH) agonist protocols are used. With the combination of r-hFSH and r-hLH for COS in a non-selected group of subjects undergoing IVF, no significant statistical differences were obtained with respect to the use of r-hFSH alone. The analysis of the subpopulation with deep pituitary suppression or those who required elevated doses of r-hFSH indicated that the use of r-hLH can be positive in terms of the quality of oocytes and increase in pregnancy rates. Preliminary data had been published in favour of adding r-hLH as rescue treatment to increase the quality of oocytes in young subjects subjected to IVF, who present little response to the conventional doses of FSH, which indicates a strong suppression of the endogenous LH.
- To evaluate the efficacy of adding r-hLH in the middle of the follicular phase compared to the non addition of r-hLH in subjects, subjected to COS with r-hFSH for practicing IVF/ICSI and ET, in terms of the quality of oocytes, follicular development, fertilisation of the oocytes, quality of embryos and pregnancy rates
- To evaluate the safety of r-hLH when combined with r-hFSH for the symptom listed in the above objective, including the incidence of ovarian hyperstimulation syndrome (OHSS), general adverse occurrences and local reactions at the injection area
This study was performed on an out-patient basis where all the subjects received one treatment cycle of pituitary desensibilization with GnRH agonist (GnRH-a). The desensibilization was commenced at the middle of the luteinic phase (long protocol). Once the decrease in pituitary activity was confirmed using estradiol (E2) < 50 pg/ml (180 pmol/l) as criteria, COS was initiated with an r-hFSH dosage of 300-450 IU administered subcutaneously (sc). On Day 6 of stimulation (S6), subjects were randomly assigned to an additional treatment with r-hLH with a fixed dosage of 150 IU or were continued to be treated with r-hFSH alone. The first dose of r-hLH was administered late in the evening on the day the randomisation was carried out (S6).
The combined treatment with r-hLH + r-hFSH or treatment with r-hFSH alone was administered until the follicular development was adequate as judged by the investigator (evaluated through ovarian ultrasound and determination of the serum levels of E2). A sole injection of 250 mcg of human recombinant chorionic gonadotropin (r-hCG) was administered in order to achieve the follicular maturation within the 36 hours following the last dose of r-hFSH, r-hLH and GnRH-a. The r-hCG was not administered until at least one follicle has reached an average diameter > 18 mm and other follicles of diameter > 16 mm and the E2 levels are proportional in number and size to the follicles that are present. The oocytes were collected 34-38 hours after administering the r-hCG and were evaluated and fertilised in-vitro through ICSI. No more than 3 embryos were implanted on Days 2-4 after the oocyte retrieval(ovum pick-up).
The luteinic phase was supported through the daily administration of natural progesterone via the vaginal route, starting after the ovum pick-up (OPU) and continuing until the moment of menstruation or until the pregnancy test; or, if the subject is pregnant, for at least 30 days after obtaining a positive result in the laboratory pregnancy test. A monitoring of subjects was carried out and the result of the treatment was recorded (pregnancy or menstruation).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Recombinant human follicle stimulating hormone, Recombinant human luteinizing hormone (Luveris)
Hospital de Cruces, Plaza de Cruces, 12, 48903
Published on BioPortfolio: 2014-07-24T14:05:57-0400
The follicular phase of the menstrual cycle involves the hourly release of gonadotropin-releasing hormone, which binds to receptors on the gonadotropes. This results in the secretion of fo...
Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing 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) >350...
Brief Summary: LM001 is a recombinant human Follicle Stimulating Hormone (r-hFSH) Injection, which is proposed for Assisted Reproductive Technology (ART). This is a randomized, open-label,...
Low testosterone affects more than 10% of men worldwide, with high incidence in the elderly.This will be a prospective case study. The investigators will identify men with hypogonadism in ...
The aim of this study was to evaluate the efficacy and safety of domestic recombinant human follicle stimulating hormone (rhFSH) stimulating ovarian to promote follicular development befor...
To characterize US clinical laboratory reference range reporting and testing methods of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, prolactin.
Patients with homozygous intronic pseudoexon GH receptor(GHR) mutations(6Ψ) have growth hormone Insensitivity(GHI) (growth failure, IGF1 deficiency and normal/elevated serum GH). We report 9 patients...
Cytotoxic analogs of LHRH (luteinizing hormone-releasing hormone) can be successfully used for the treatment of hormone-dependent cancers such as prostatic, ovarian, endometrial, but our knowledge abo...
Luteinizing hormone receptor (LHR) plays a critical role in reproduction by mediating LH signaling in the gonad. In this study, we cloned a novel lhr gene from the orange-spotted grouper, named glhr2....
Morphological changes of the uterus and alterations in its secretory activity under the influence of steroid hormones been well documented. The estrous cycle is also associated with significant change...
Receptors with a 6-kDa protein on the surfaces of cells that secrete LUTEINIZING HORMONE or FOLLICLE STIMULATING HORMONE, usually in the adenohypophysis. LUTEINIZING HORMONE-RELEASING HORMONE binds to these receptors, is endocytosed with the receptor and, in the cell, triggers the release of LUTEINIZING HORMONE or FOLLICLE STIMULATING HORMONE by the cell. These receptors are also found in rat gonads. INHIBINS prevent the binding of GnRH to its receptors.
A major gonadotropin secreted by the human adenohypophysis (PITUITARY GLAND, ANTERIOR). Follicle-stimulating hormone stimulates GAMETOGENESIS and the supporting cells such as the ovarian GRANULOSA CELLS, the testicular SERTOLI CELLS, and the LEYDIG CELLS. FSH consists of two noncovalently linked subunits, alpha and beta. The alpha subunit is common in the three human pituitary glycoprotein hormones (TSH, LH, and FSH), but the beta subunit is unique and confers its biological specificity.
A protein extract of human menopausal urine in which LUTEINIZING HORMONE has been partially or completely removed. Urofollitropin represents FOLLICLE STIMULATING HORMONE from the urine.
Anterior pituitary cells that can produce both FOLLICLE STIMULATING HORMONE and LUTEINIZING HORMONE.
A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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...
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...