Can you mix bravelle and menopur

Participants assigned to the Menopur and Bravelle treatment arm prepared and self-administered her daily dose on Day 6 in the presence of the study coordinator or designee assessor. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

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Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : April 24, Last Update Posted : May 16, Study Description. The objective of this study was to compare the fertilization rate between the combination of Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered subcutaneously SC , in subjects undergoing Assisted Reproductive Technology ART.

Additionally the study assessed subjects' ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination. FDA Resources. Arms and Interventions.

The initial daily dose consisted of IU of Menopur administered by subcutaneous SC injection for 5 days. Outcome Measures. Primary Outcome Measures : Fertilization Rate [ Time Frame: approximately day 13 hours post insemination by in vitro fertilization IVF insemination or intracytoplasmic sperm injection ICSI ] The fertilization rate was defined for each participant and calculated as the number of 2 pronuclei fertilized 2PN oocytes divided by the total number of oocytes retrieved multiplied by Subject comprehension questionnaires were repeated on Day 6 after 5 days of combination therapy by participants assigned to the Menopur and Bravelle treatment arm.

Participants assigned to the Menopur and Bravelle treatment arm read the Mixing Instructions Guide on how to mix and administer the medications at home. A treatment-emergent AE was any AE occurring after start of investigational medicinal product IMP and within the time of residual drug effect, or a pretreatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect.

The time of residual drug effect was the estimated period of time after the last dose of the IMP, where the effect of the product was still considered to be present based on pharmacokinetic, pharmacodynamic, or other IMP characteristics.

Eligibility Criteria. Main Inclusion Criteria: Infertile pre-menopausal female subjects Documented history of infertility eg. Subject's male partner with semen analysis that was at least adequate for intracytoplasmic sperm injection ICSI within 6 months prior to the subjects beginning down-regulation with gonadotropin-releasing hormone GnRH -agonist.

Partners with severe male factor requiring invasive or surgical sperm retrieval or donor sperm could have been used. Main Exclusion Criteria: Oocyte donor or embryo recipient; gestational or surrogate carrier Previous IVF or assisted reproductive technology ART failure due to a poor response to gonadotropins. Inadequate number of oocytes, defined as fewer than 5 oocytes retrieved in previous ART attempts.

If either of these conditions existed, the male was to be treated with antibiotics and retested prior to subject's pituitary down-regulation. The bioactivities of the five groups expressed as a percent of the labeled claims are shown in Figure 1a. Theoretical vs. B LH bioactivities of Menopur and the three ratios of Bravelle and Menopur expressed as a percent of labeled claim. As expected, seminal vesicle weights increased with increasing doses of LH Table 3. The bioactivities of the four groups expressed as a percent of the labeled claims are shown in Figure 1b.

In many cases, physicians are administering FSH and hMG as separate injections because of concerns that different gonadotropins may not be compatible, which could result in unexpected results during controlled ovarian hyperstimulaiton COH cycles.

It is well known that even structurally similar proteins, expecially those of high molecular weight can be incompatible. Nonetheless, in an effort to minimize the number of injections that a woman must take while undergoing COH, some physicians are combining FSH and hMG in the same syringe.

The charge distribution described by the isoelectric point and the carbohydrate complexity simple, intermediate and complex carbohydrates of recombinant FSH was found to be quite different when compared with serum FSH throughout the menstrual cycle [ 11 ].

Therefore, when hormones with different chemical configurations are reconstituted in different diluents and mixed, their compatibility and possibly their bioactivity may be affected. A previous study demonstrated that the activity of peptides may be significantly changed by the diluents in which they are dissolved [ 12 ] or the characteristic of the vessel used for mixing. Studies have shown that peptides and proteins adhere to certain surfaces [ 13 ].

Surface adsorption of calcitonin on soda lime silica glass is pH dependent [ 13 ]. Fibrinogen adheres to both dimethyldichlorosilane-treated glass and low-density polyethylene [ 14 ]. We must emphasize that the results from this study and a previously published study [ 7 ] were obtained with FSH and LH activity containing preparations from a single manufacturer Ferring Pharmaceuticals Inc.

These data cannot be extended to other preparations of gonadotropins, particularly if recombinant hormones that require bacteriostatic water for reconstitution or other delivery vehicles are mixed with human-derived hormone preparations. J Clin Endocrinol Metab. March CM: Human menopausal gonadotropins. Infertility and reproductive medicine. Clinics of North America. Google Scholar. Acta Endocrinol Copenh. CAS Google Scholar. Hum Reprod. Today's Therapeutic Trends.

The United States Pharmacopeia, 26th rev. Reprod Biol Endocrinol. Fert Ster. Am J Hosp Pharm. Drug Dev Ind Pharm. Reprod Biol Endocrin. Download references. Ferring Pharmaceuticals Inc. You can also search for this author in PubMed Google Scholar.

Correspondence to M Joseph Scobey. Reprints and Permissions. Scobey, M. Reprod Biol Endocrinol 3, 61 Download citation. Received : 06 June Accepted : 09 November Published : 09 November Anyone you share the following link with will be able to read this content:. Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative. Skip to main content. Search all BMC articles Search. Download PDF. Abstract Background The use of mixed or blended protocols, that utilize both FSH and hMG, for controlled ovarian hyperstimulation is increasing in use. Methods Bravelle R and Menopur R were reconstituted in 0. Introduction Greep and co-workers [ 1 ] were the first to demonstrate that follicle stimulating hormone FSH and luteinizing hormone LH were distinct chemical moieties and that both were necessary for follicular growth, ovulation and formation of the corpus luteum.

Materials and methods Study Design Validated methods [ 8 ], specified by the United States Pharmacopeia USP , were used to determine the bioactivities of each product individually and subsequent mixtures of the two. Control Solution The Reference Standard diluent was used as the control solution for both assays. FSH assay Each female rat was injected subcutaneously with 0.

LH assay Each male rat was injected with 0. Statistical analysis An analysis of variance ANOVA was performed to determine if there were differences among ovarian or seminal vesicle weights between replicates. Full size table.