Delving into the Latest Updates on Choriogonadotropin alfa with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

Choriogonadotropin Alfa (Genetical Recombination), Choriogonadotropin alfa (USAN/INN), Choriogonadotropin alfa (genetical recombination) (JAN)

+ [12]

Target

FSHR x LHCGR

Mechanism

FSHR agonists(Follicle-stimulating hormone receptor agonists), LHCGR agonists(Luteinizing hormone/Choriogonadotropin receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic DiseaseUrogenital Diseases

Active Indication

Infertility, FemaleInfertilityHypogonadism

Inactive Indication

AnovulationFunctional disorderHypothalamic Diseases+ [1]

Originator Organization

Merck Serono SA

Active Organization

Merck Biopharma Co., Ltd.Merck Europe BVMerck Serono SA

+ [2]

Inactive Organization

Merck KGaA

Drug Highest PhaseApproved

First Approval Date

US (05 Mar 1973),

Hypogonadism

Regulation-

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Gene Sequence

Sequence Code 3246

Source: *****

Sequence Code 51997

Source: *****

This sponsor is an anti-doping laboratory tasked with testing athlete samples for prohibited substances by the World Anti-Doping Agency and other agencies.
This study is intended to measure:
Urinary/serum hCG (human chorionic gonadotropin) and urinary biotin concentrations in both treatment groups before, during, and after hCG intervention using standard immunoassay methods
To monitor hCG in both treatment groups before and after diafiltration of urine samples prior to analysis
To compare urinary and serum detectability (detection window, sensitivity) of hCG abuse in the hCG-only group compared to the hCG + biotin group

Start Date27 Oct 2022

Sponsor / Collaborator

Sports Medicine Research & Testing Laboratory

NCT05838105 / RecruitingNot ApplicableIIT

Prospective Randomized Control Study of Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates

The aim of the study is to compare the pregnancy rate between women treated with Gonadotropin Releasing Hormone (GnRH) agonist together with Human Chorionic Gonadotropin (HCG) and standard luteal support with progesterone following transfer of frozen embryos in in-vitro-fertilization (IVF) natural cycles.

Start Date01 Oct 2022

Sponsor / Collaborator

Shaare Zedek Medical Center

100 Clinical Results associated with Choriogonadotropin alfa

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100 Translational Medicine associated with Choriogonadotropin alfa

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100 Patents (Medical) associated with Choriogonadotropin alfa

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172

Literatures (Medical) associated with Choriogonadotropin alfa

01 Jul 2024·Reproductive BioMedicine Online

Modified natural cycle allows a window of 7 days for frozen embryo transfer planning

Article

Author: Alonso-Mayo, Carlos ; Soares, Sergio Reis ; Garcia-Velasco, Juan A ; Kohls, Graciela ; Santos-Ribeiro, Samuel

RESEARCH QUESTIONShould ovulation be triggered in a modified natural cycle (mNC) with recombinant human chorionic gonadotrophin (rHCG) as soon as a mean follicle diameter of 17 mm is visible, or is more flexible planning possible?DESIGNThis multicentre, retrospective, observational study of 3087 single frozen blastocyst transfers in mNC was carried out between January 2020 and September 2022. The inclusion criteria included endometrial thickness ≥7 mm and serum progesterone <1.5 ng/ml. The main outcome was ongoing pregnancy rate. Secondary end-points were pregnancy rate, implantation rate, clinical pregnancy rate and miscarriage rate. The mean follicle size at triggering was stratified into three groups (13.0-15.9, 16.0-18.9 and 19.0-22 mm).RESULTSThe baseline characteristics between the groups did not vary significantly for age, body mass index and the donor's age for egg donation. No differences were found in pregnancy rate (64.5%, 60.2% and 57.4%; P = 0.19), clinical pregnancy rate (60.5%, 52.8% and 50.6%; P = 0.10), implantation rate (62.10%, 52.9% and 51.0%; P = 0.05) or miscarriage rate (15.0%, 22.2%; and 25.0%; P = 0.11). Although ongoing pregnancy rate (54.9%, 46.8% and 43.1%; P = 0.02) varied significantly in the univariable analysis, it was no longer significant after adjustment for the use of preimplantation genetic testing for aneuploidies and egg donation.CONCLUSIONSThe findings showed rHCG could be flexibly administered with a mean follicle size between 13 and 22 mm as long as adequate endometrial characteristics are met, and serum progesterone is <1.5 ng/ml. Considering the follicular growth rate of 1-1.5 mm/day, this approach could allow a flexibility for FET scheduling of 6-7 days, simplifying mNC FET planning in clinical practice.

01 Jul 2024·Human Reproduction

Circadian serum progesterone variations on the day of frozen embryo transfer in a modified natural cycle protocol

Article

Author: Niero, M ; Blockeel, C ; Roelens, C ; Loreti, S ; Tournaye, H ; Aktoz, F ; Mackens, S ; De Munck, N

AbstractSTUDY QUESTIONIs there a circadian variation of serum progesterone (P) on the day of frozen embryo transfer (FET) in a modified natural cycle (mNC)?SUMMARY ANSWERThere is a statistically significant diurnal variation of serum P on the day of a FET in an mNC protocol.WHAT IS KNOWN ALREADYIn recent years, the proportion of FET cycles has increased dramatically. To further optimize pregnancy outcomes after FET, recent studies have focused on serum luteal P levels in both natural and artificially prepared FET cycles. Despite the different cut-off values proposed to define low serum P in the NC, it is generally accepted that lower serum P values (<10 ng/ml) around the day of FET are associated with negative reproductive outcomes. However, a single serum P measurement is not reliable given that P levels are prone to diurnal fluctuations and are impacted by patients’ characteristics.STUDY DESIGN, SIZE, DURATIONA prospective cohort study was conducted in a single university-affiliated fertility center, including 22 patients performing a single blastocyst mNC-FET from August 2022 to August 2023. Serum P levels were measured on the day of transfer at 08:00h, 12:00h, 16:00h, and 20:00h. Differences between P levels were compared using the Wilcoxon signed-rank test. The sample size was calculated to detect a difference of 15% between the first and last P measurements with a 5% false-positive rate and a 95% CI.PARTICIPANTS/MATERIALS, SETTING, METHODSPatients with a normal BMI, between 18 and 40 years old, without uterine diseases were eligible. Patients utilizing donated oocytes were excluded. The mNC-FET protocol involved monitoring the normal ovarian cycle and triggering ovulation with an injection of 250 μg of choriogonadotropin alfa when a pre-ovulatory follicle (16–20 mm diameter) was visualized. The blastocyst was transferred seven days later. The patients were not supplemented with exogenous P at any time before the day of the FET.MAIN RESULTS AND THE ROLE OF CHANCEThe mean age and BMI of the study population were 33.6 ± 3.8 years and 22.7 ± 1.8 kg/m2, respectively. Mean P values at 08:00h, 12:00h, 16:00h, and 20:00h were 14.6 ± 4.5, 14.7 ± 4.1, 12.9 ± 3.5, and 14.6 ± 4.3 ng/ml, respectively. The mean P levels at 16:00h were significantly lower compared to all other time points (P < 0.05: P = 0.007 between P at 8:00h and 16:00h; P = 0.003 between P at 12:00h and 16:00h; P = 0.007 between P at 16:00h and 20:00h). No statistically significant difference was observed between P values at the other time points (P > 0.05: P = 0.88 between P at 8:00h and 12:00h; P = 0.96 between P at 8:00h and 20:00h; P = 0.83 between P at 12:00h and 20:00h).LIMITATIONS, REASONS FOR CAUTIONThe study’s limitations include the small sample size that may cause a bias when the results are extrapolated to a larger subfertile population undergoing mNC-FET. Ideally, larger prospective trials including a more heterogeneous patient population would be necessary to validate our findings.WIDER IMPLICATIONS OF THE FINDINGSThe current study demonstrates the existence of a diurnal fluctuation of serum P on the day of mNC-FET highlighting the importance of a standardized time point for its measurement. This is especially important for considering clinical actions, such as additional exogenous P supplementation, when encountering P values lower than 10 ng/ml on the day of FET.STUDY FUNDING/COMPETING INTEREST(S)No funding was obtained for the study. The authors have no conflicts of interest to declare regarding the content of the study.TRIAL REGISTRATION NUMBERNCT05511272.

01 Jul 2024·Clinical Endocrinology

Single and multi‐dose pharmacology of recombinant and urinary human chorionic gonadotrophin in men

Article

Author: Grainger, Janelle ; Conway, Ann J ; Desai, Reena ; Savkovic, Sasha ; Handelsman, David J ; Sleiman, Sue ; Kouzios, Dorothy ; Idan, Amanda ; Goebel, Catrin ; Jayadev, Venna

AbstractObjectiveHuman choriogonadotrophin (hCG) treatment of gonadotrophin‐deficient infertile men uses hCG of urinary (uhCG) or recombinant (rhCG) origin, but these treatments have not been compared nor are there studies defining rhCG dosing in men.DesignhCG products were studied in randomized cross‐over single‐dose studies of standard (Study 1, 1500 IU and 62.5 µg, respectively) or high (Study 2, 5000 IU and 250 µg) dose and a multi‐dose population pharmacology study of hCG use.ParticipantsEight (Study 1) and seven (Study 2) volunteers in cross‐over and 52 gonadotrophin‐deficient men in the multi‐dose studyMeasurementsIn cross‐over studies, serum testosterone (T), dihydrotestosterone (DHT) and estradiol by liquid chromatography‐mass spectrometry (LCMS) and serum hCG, LH, FSH, SHBG and T (observational study) by immunoassays.ResultsAfter standard and high‐dose injection, serum hCG and testosterone responses had similar timing and peak concentrations except for a mildly lower early (<48 h) serum testosterone with uhCG. In the multi‐dosing study, both hCGs had similar pharmacokinetics (pooled half‐life 5.8 days, p < .001), while serum testosterone concentrations were stable after injection and did not differ between hCG products. Bench testing verified that 20% of pens from 4/10 individuals were used inappropriately.ConclusionsAlthough hCG pharmacokinetics are not formally bioequivalent, the similar pharmacodynamic effects on serum testosterone indicate that at the doses tested both hCGs provide comparable clinical effects. The starting dose of rhCG for treating gonadotrophin‐deficient men should be 62.5 µg (6 clicks) of the rhCG pen.

100 Deals associated with Choriogonadotropin alfa

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External Link

KEGG	Wiki	ATC	Drug Bank
D03478	Choriogonadotropin alfa	G03GA08	DB00097

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Infertility, Female	EU	Merck Europe BV	02 Feb 2001
Infertility, Female	NO	Merck Europe BV	02 Feb 2001
Infertility, Female	LI	Merck Europe BV	02 Feb 2001
Infertility, Female	IS	Merck Europe BV	02 Feb 2001
Infertility	US	EMD Serono, Inc.	20 Sep 2000
Hypogonadism	US	Fresenius SE & Co. KGaA	05 Mar 1973

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anovulation	Phase 2	JP	Merck KGaA	01 Sep 2012
Functional disorder	Phase 2	JP	Merck KGaA	01 Sep 2012
Hypothalamic Diseases	Phase 2	JP	Merck KGaA	01 Sep 2012
Polycystic Ovary Syndrome	Phase 2	JP	Merck KGaA	01 Sep 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01112358 (CTgov)	Phase 2	Ovarian Stimulations	58	Analogous GnRH antagonist+r-hCG+Progesterone+r-hLH+r-FSH (r-FSH + r-hLH)	vblbxgdidg(mvbubyhzqo) = lhlfulufjc bucukttwrr (pjxabfalnq, xhvqlzappb - ftcsiuckww) View more	-	30 Jul 2018
				Analogous GnRH antagonist+r-hCG+Progesterone+r-FSH (r-FSH)	vblbxgdidg(mvbubyhzqo) = hnpawfshui bucukttwrr (pjxabfalnq, epeylezdqt - zuxhiwfxys) View more
NCT00249834 (CONSORT, CTgov)	Phase 4	Infertility	166	Recombinant human chorionic gonadotrophin (r-hCG)+Gonal-f (Gonal-f 75 IU)	fxxyavhrir(cvumjzwsbc) = ztuthogqcj bjbrexkgbd (eojzyldfkl, dwjwwobvgd - dhpbgqfhis) View more	-	30 Mar 2018
				Recombinant human chorionic gonadotrophin (r-hCG)+Gonal-f (Gonal-f 112.5 IU)	fxxyavhrir(cvumjzwsbc) = aocylvqfme bjbrexkgbd (eojzyldfkl, rajdeyhunr - jxrdiesmbc) View more
NCT02047227 (ESPART, CTgov)	Phase 3	Infertility	939	rhLH+r-hCG+lutropin alfa+follitropin alfa+Pergoveris (Pergoveris)	plzvhwfqsc(hyaosyelyk) = sbcxwcjauf uexqezicwc (ypoilmoznh, dlimvivxjo - helzuaeabo) View more	-	24 Jan 2017
				GONAL-f (r-hFSH)+r-hCG+r-hFSH (GONAL-f)	plzvhwfqsc(hyaosyelyk) = lgpciduqgd uexqezicwc (ypoilmoznh, zlnxdnlxeo - htbolybkxu) View more
NCT01653743 (CTgov)	Phase 3	Functional disorder \| Polycystic Ovary Syndrome \| Anovulation	81	MSJ-0011+Follitropin alpha	ckmsipqonc(zukbarqxma) = mmonmumxkf ctzzcefwaf (buyvvldemv, gavwfrbttq - iavmxkmnfp) View more	-	07 Jan 2016
NCT01297465 (PERSIST, CTgov)	Phase 3	Infertility	202	Recombinant human chorionic gonadotropin (r-hCG)+Gonal-f®+Pergoveris® (Gonal-f® Plus Pergoveris®)	gfvpilnmqs(ubfjlnnoic) = lwnickdkni mscrzsesrw (dgngudbkrz, dobmdnczhq - nrgyrliuoh) View more	-	24 Feb 2014
				Recombinant human chorionic gonadotropin (r-hCG)+Pergoveris® (Pergoveris®)	gfvpilnmqs(ubfjlnnoic) = groelwoplj mscrzsesrw (dgngudbkrz, zvxxxlgfsm - ftnxkngckb) View more
NCT00553514 (CTgov)	Phase 2	Infertility	71	Recombinant human chorionic gonadotropin (r-hCG)+AS900672-Enriched 10 microgram (mcg)+Follitropin alfa 75 international unit (IU) (AS900672-Enriched 10 Mcg)	zmlwsndocm(vsesauicua) = doyjrmrxjg xdwnkdncji (hznqrmfqwk, wrzpgkmgmq - iaewuasuem) View more	-	25 Jul 2013
				Recombinant human chorionic gonadotropin (r-hCG)+AS900672-Enriched 20 mcg+Follitropin alfa 75 international unit (IU) (AS900672-Enriched 20 Mcg)	zmlwsndocm(vsesauicua) = yovmcawbwv xdwnkdncji (hznqrmfqwk, shnoxwtqqf - ftbameabnj) View more
NCT00505752 (CTgov)	Phase 2	Infertility	520	Recombinant human chorionic gonadotropin (r-hCG)+AS900672-Enriched 50 microgram (mcg)+Follitropin alfa 150 international unit (IU) (AS900672-Enriched 50 Mcg)	glildvsksg(hyofpuuckz) = ljybgujyuh lwnkomkscl (qzihpyeazu, uoucfavvpk - vaezsrseyu) View more	-	24 Jul 2013
				Recombinant human chorionic gonadotropin (r-hCG)+Follitropin alfa 150 international unit (IU) (Follitropin Alfa 150 IU)	glildvsksg(hyofpuuckz) = ctjyhmyaki lwnkomkscl (qzihpyeazu, fuyuolkfyq - yfxymlmwwq) View more
NCT00328926 (CTgov)	Phase 4	secondary testicular failure	11	Recombinant human chorionic gonadotropin (r-hCG)+Luveris® 75 IU+Recombinant human follicle stimulating hormone (r-hFSH) (Luveris® 75 IU)	hnvpxavwpl(xaaijqgoug) = mhaggxgwwn xkbvesbgkt (nwywgblfiq, qhrsmndnlz - zibpgvqslu) View more	-	12 Jul 2013
				Recombinant human chorionic gonadotropin (r-hCG)+Luveris® 25 IU+Recombinant human follicle stimulating hormone (r-hFSH) (Luveris® 25 IU)	hnvpxavwpl(xaaijqgoug) = lynnbtmnda xkbvesbgkt (nwywgblfiq, yiboxonwmy - mhlmrbatpp) View more
NCT01185704 (ATTAC-PCO, CTgov)	Phase 3	Polycystic Ovary Syndrome	136	Cetrorelix acetate+Recombinant Human Choriogonadotropin (r-hCG)+Recombinant human follicle stimulating hormone (r-hFSH) (Day 1 Protocol)	ixoxfiapio(brcvanszsl) = zwjxmprzav smgqvuysfw (pepykiillm, exiyahsama - fdhntajavt) View more	-	03 Jul 2013
				Cetrorelix acetate+Recombinant Human Choriogonadotropin (r-hCG)+Recombinant human follicle stimulating hormone (r-hFSH) (Day 7 Protocol)	ixoxfiapio(brcvanszsl) = kzgobkmoff smgqvuysfw (pepykiillm, udqlrerxzj - qnwofsyfky) View more
NCT01079949 (CTgov)	Phase 2	Infertility	93	GnRH antagonist+Recombinant Human Choriogonadotropin (r-hCG)+r-hFSH	zrihfxnsgi(dnqlelurtn) = zleggnctlq fcnofladmk (idokrcuobn, eezjhxegcv - yskhajevvf) View more	-	20 Feb 2013